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2011 Florida Statutes
Chapter 408
HEALTH CARE ADMINISTRATION
HEALTH CARE ADMINISTRATION
CHAPTER 408
HEALTH CARE ADMINISTRATION
PART I
HEALTH FACILITY AND SERVICES PLANNING(ss. 408.031-408.7071)
PART II
HEALTH CARE LICENSING: GENERAL PROVISIONS(ss. 408.801-408.832)
PART III
HEALTH INSURANCE ACCESS(ss. 408.909-408.910)
PART IV
HEALTH AND HUMAN SERVICES ELIGIBILITY ACCESS SYSTEM(ss. 408.911-408.918)
PART I
HEALTH FACILITY AND SERVICES PLANNING408.031 Short title.
408.032 Definitions relating to Health Facility and Services Development Act.
408.033 Local and state health planning.
408.034 Duties and responsibilities of agency; rules.
408.035 Review criteria.
408.036 Projects subject to review; exemptions.
408.0361 Cardiovascular services and burn unit licensure.
408.037 Application content.
408.038 Fees.
408.039 Review process.
408.040 Conditions and monitoring.
408.041 Certificate of need required; penalties.
408.042 Limitation on transfer.
408.043 Special provisions.
408.0435 Moratorium on nursing home certificates of need.
408.044 Injunction.
408.045 Certificate of need; competitive sealed proposals.
408.0455 Rules; pending proceedings.
408.05 Florida Center for Health Information and Policy Analysis.
408.051 Florida Electronic Health Records Exchange Act.
408.0512 Electronic health records system adoption loan program.
408.061 Data collection; uniform systems of financial reporting; information relating to physician charges; confidential information; immunity.
408.0611 Electronic prescribing clearinghouse.
408.062 Research, analyses, studies, and reports.
408.063 Dissemination of health care information.
408.07 Definitions.
408.08 Inspections and audits; violations; penalties; fines; enforcement.
408.09 Assistance on cost containment strategies.
408.10 Consumer complaints.
408.15 Powers of the agency.
408.16 Health Care Trust Fund; moneys to be deposited therein.
408.18 Health Care Community Antitrust Guidance Act; antitrust no-action letter; market-information collection and education.
408.185 Information submitted for review of antitrust issues; confidentiality.
408.20 Assessments; Health Care Trust Fund.
408.301 Legislative findings.
408.302 Interagency agreement.
408.40 Public Counsel.
408.50 Prospective payment arrangements.
408.70 Health care; managed competition; legislative findings and intent.
408.7056 Subscriber Assistance Program.
408.7057 Statewide provider and health plan claim dispute resolution program.
408.7071 Standardized claim form.
408.031 Short title.—Sections 408.031-408.045 shall be known and may be cited as the “Health Facility and Services Development Act.”
History.—s. 18, ch. 87-92; s. 15, ch. 92-33; s. 7, ch. 95-144.
Note.—Former s. 381.701.
408.032 Definitions relating to Health Facility and Services Development Act.—As used in ss. 408.031-408.045, the term:
(1) “Agency” means the Agency for Health Care Administration.
(2) “Capital expenditure” means an expenditure, including an expenditure for a construction project undertaken by a health care facility as its own contractor, which, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance, which is made to change the bed capacity of the facility, or substantially change the services or service area of the health care facility, health service provider, or hospice, and which includes the cost of the studies, surveys, designs, plans, working drawings, specifications, initial financing costs, and other activities essential to acquisition, improvement, expansion, or replacement of the plant and equipment.
(3) “Certificate of need” means a written statement issued by the agency evidencing community need for a new, converted, expanded, or otherwise significantly modified health care facility, health service, or hospice.
(4) “Commenced construction” means initiation of and continuous activities beyond site preparation associated with erecting or modifying a health care facility, including procurement of a building permit applying the use of agency-approved construction documents, proof of an executed owner/contractor agreement or an irrevocable or binding forced account, and actual undertaking of foundation forming with steel installation and concrete placing.
(5) “District” means a health service planning district composed of the following counties:
District 1.—Escambia, Santa Rosa, Okaloosa, and Walton Counties.
District 2.—Holmes, Washington, Bay, Jackson, Franklin, Gulf, Gadsden, Liberty, Calhoun, Leon, Wakulla, Jefferson, Madison, and Taylor Counties.
District 3.—Hamilton, Suwannee, Lafayette, Dixie, Columbia, Gilchrist, Levy, Union, Bradford, Putnam, Alachua, Marion, Citrus, Hernando, Sumter, and Lake Counties.
District 4.—Baker, Nassau, Duval, Clay, St. Johns, Flagler, and Volusia Counties.
District 5.—Pasco and Pinellas Counties.
District 6.—Hillsborough, Manatee, Polk, Hardee, and Highlands Counties.
District 7.—Seminole, Orange, Osceola, and Brevard Counties.
District 8.—Sarasota, DeSoto, Charlotte, Lee, Glades, Hendry, and Collier Counties.
District 9.—Indian River, Okeechobee, St. Lucie, Martin, and Palm Beach Counties.
District 10.—Broward County.
District 11.—Miami-Dade and Monroe Counties.
(6) “Exemption” means the process by which a proposal that would otherwise require a certificate of need may proceed without a certificate of need.
(7) “Expedited review” means the process by which certain types of applications are not subject to the review cycle requirements contained in s. 408.039(1), and the letter of intent requirements contained in s. 408.039(2).
(8) “Health care facility” means a hospital, long-term care hospital, skilled nursing facility, hospice, or intermediate care facility for the developmentally disabled. A facility relying solely on spiritual means through prayer for healing is not included as a health care facility.
(9) “Health services” means inpatient diagnostic, curative, or comprehensive medical rehabilitative services and includes mental health services. Obstetric services are not health services for purposes of ss. 408.031-408.045.
(10) “Hospice” or “hospice program” means a hospice as defined in part IV of chapter 400.
(11) “Hospital” means a health care facility licensed under chapter 395.
(12) “Intermediate care facility for the developmentally disabled” means a residential facility licensed under chapter 393 and certified by the Federal Government pursuant to the Social Security Act as a provider of Medicaid services to persons who are mentally retarded or who have a related condition.
(13) “Long-term care hospital” means a hospital licensed under chapter 395 which meets the requirements of 42 C.F.R. s. 412.23(e) and seeks exclusion from the acute care Medicare prospective payment system for inpatient hospital services.
(14) “Mental health services” means inpatient services provided in a hospital licensed under chapter 395 and listed on the hospital license as psychiatric beds for adults; psychiatric beds for children and adolescents; intensive residential treatment beds for children and adolescents; substance abuse beds for adults; or substance abuse beds for children and adolescents.
(15) “Nursing home geographically underserved area” means:
(a) A county in which there is no existing or approved nursing home;
(b) An area with a radius of at least 20 miles in which there is no existing or approved nursing home; or
(c) An area with a radius of at least 20 miles in which all existing nursing homes have maintained at least a 95 percent occupancy rate for the most recent 6 months or a 90 percent occupancy rate for the most recent 12 months.
(16) “Skilled nursing facility” means an institution, or a distinct part of an institution, which is primarily engaged in providing, to inpatients, skilled nursing care and related services for patients who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.
(17) “Tertiary health service” means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service. Examples of such service include, but are not limited to, pediatric cardiac catheterization, pediatric open-heart surgery, organ transplantation, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. The agency shall establish by rule a list of all tertiary health services.
History.—s. 19, ch. 87-92; s. 19, ch. 88-294; s. 2, ch. 89-308; s. 7, ch. 89-354; s. 21, ch. 91-158; s. 54, ch. 91-221; s. 1, ch. 91-282; ss. 15, 16, ch. 92-33; s. 10, ch. 92-58; s. 22, ch. 93-214; s. 8, ch. 95-144; s. 28, ch. 95-210; s. 2, ch. 95-394; s. 1, ch. 97-270; s. 3, ch. 2000-256; s. 4, ch. 2000-318; s. 2, ch. 2004-383; s. 74, ch. 2006-197; s. 111, ch. 2008-4.
Note.—Former s. 381.702.
408.033 Local and state health planning.—
(1) LOCAL HEALTH COUNCILS.—
(a) Local health councils are hereby established as public or private nonprofit agencies serving the counties of a district. The members of each council shall be appointed in an equitable manner by the county commissions having jurisdiction in the respective district. Each council shall be composed of a number of persons equal to 11/2 times the number of counties which compose the district or 12 members, whichever is greater. Each county in a district shall be entitled to at least one member on the council. The balance of the membership of the council shall be allocated among the counties of the district on the basis of population rounded to the nearest whole number; except that in a district composed of only two counties, no county shall have fewer than four members. The appointees shall be representatives of health care providers, health care purchasers, and nongovernmental health care consumers, but not excluding elected government officials. The members of the consumer group shall include a representative number of persons over 60 years of age. A majority of council members shall consist of health care purchasers and health care consumers. The local health council shall provide each county commission a schedule for appointing council members to ensure that council membership complies with the requirements of this paragraph. The members of the local health council shall elect a chair. Members shall serve for terms of 2 years and may be eligible for reappointment.
(b) Each local health council may:
1. Develop a district area health plan that permits each local health council to develop strategies and set priorities for implementation based on its unique local health needs.
2. Advise the agency on health care issues and resource allocations.
3. Promote public awareness of community health needs, emphasizing health promotion and cost-effective health service selection.
4. Collect data and conduct analyses and studies related to health care needs of the district, including the needs of medically indigent persons, and assist the agency and other state agencies in carrying out data collection activities that relate to the functions in this subsection.
5. Monitor the onsite construction progress, if any, of certificate-of-need approved projects and report council findings to the agency on forms provided by the agency.
6. Advise and assist any regional planning councils within each district that have elected to address health issues in their strategic regional policy plans with the development of the health element of the plans to address the health goals and policies in the State Comprehensive Plan.
7. Advise and assist local governments within each district on the development of an optional health plan element of the comprehensive plan provided in chapter 163, to assure compatibility with the health goals and policies in the State Comprehensive Plan and district health plan. To facilitate the implementation of this section, the local health council shall annually provide the local governments in its service area, upon request, with:
a. A copy and appropriate updates of the district health plan;
b. A report of hospital and nursing home utilization statistics for facilities within the local government jurisdiction; and
c. Applicable agency rules and calculated need methodologies for health facilities and services regulated under s. 408.034 for the district served by the local health council.
8. Monitor and evaluate the adequacy, appropriateness, and effectiveness, within the district, of local, state, federal, and private funds distributed to meet the needs of the medically indigent and other underserved population groups.
9. In conjunction with the Department of Health, plan for services at the local level for persons infected with the human immunodeficiency virus.
10. Provide technical assistance to encourage and support activities by providers, purchasers, consumers, and local, regional, and state agencies in meeting the health care goals, objectives, and policies adopted by the local health council.
11. Provide the agency with data required by rule for the review of certificate-of-need applications and the projection of need for health services and facilities in the district.
(c) Local health councils may conduct public hearings pursuant to s. 408.039(3)(b).
(d) Each local health council shall enter into a memorandum of agreement with each regional planning council in its district that elects to address health issues in its strategic regional policy plan. In addition, each local health council shall enter into a memorandum of agreement with each local government that includes an optional health element in its comprehensive plan. Each memorandum of agreement must specify the manner in which each local government, regional planning council, and local health council will coordinate its activities to ensure a unified approach to health planning and implementation efforts.
(e) Local health councils may employ personnel or contract for staffing services with persons who possess appropriate qualifications to carry out the councils’ purposes. However, such personnel are not state employees.
(f) Personnel of the local health councils shall provide an annual orientation to council members about council member responsibilities.
(g) Each local health council may accept and receive, in furtherance of its health planning functions, funds, grants, and services from governmental agencies and from private or civic sources and to perform studies related to local health planning in exchange for such funds, grants, or services. Each council shall, no later than January 30 of each year, render an accounting of the receipt and disbursement of such funds received by it to the Department of Health.
(2) FUNDING.—
(a) The Legislature intends that the cost of local health councils be borne by assessments on selected health care facilities subject to facility licensure by the Agency for Health Care Administration, including abortion clinics, assisted living facilities, ambulatory surgical centers, birthing centers, clinical laboratories except community nonprofit blood banks and clinical laboratories operated by practitioners for exclusive use regulated under s. 483.035, home health agencies, hospices, hospitals, intermediate care facilities for the developmentally disabled, nursing homes, health care clinics, and multiphasic testing centers and by assessments on organizations subject to certification by the agency pursuant to chapter 641, part III, including health maintenance organizations and prepaid health clinics.
(b)1. A hospital licensed under chapter 395, a nursing home licensed under chapter 400, and an assisted living facility licensed under chapter 429 shall be assessed an annual fee based on number of beds.
2. All other facilities and organizations listed in paragraph (a) shall each be assessed an annual fee of $150.
3. Facilities operated by the Department of Children and Family Services, the Department of Health, or the Department of Corrections and any hospital which meets the definition of rural hospital pursuant to s. 395.602 are exempt from the assessment required in this subsection.
(c)1. The agency shall, by rule, establish fees for hospitals and nursing homes based on an assessment of $2 per bed. However, no such facility shall be assessed more than a total of $500 under this subsection.
2. The agency shall, by rule, establish fees for assisted living facilities based on an assessment of $1 per bed. However, no such facility shall be assessed more than a total of $150 under this subsection.
3. The agency shall, by rule, establish an annual fee of $150 for all other facilities and organizations listed in paragraph (a).
(d) The agency shall, by rule, establish a facility billing and collection process for the billing and collection of the health facility fees authorized by this subsection.
(e) A health facility which is assessed a fee under this subsection is subject to a fine of $100 per day for each day in which the facility is late in submitting its annual fee up to the maximum of the annual fee owed by the facility. A facility which refuses to pay the fee or fine is subject to the forfeiture of its license.
(f) The agency shall deposit in the Health Care Trust Fund all health care facility assessments that are assessed under this subsection and shall transfer such funds to the Department of Health for funding of the local health councils. The remaining certificate-of-need application fees shall be used only for the purpose of administering the certificate-of-need program.
(3) DUTIES AND RESPONSIBILITIES OF THE AGENCY.—
(a) The agency is responsible for the coordinated planning of health care services in the state.
(b) The agency shall develop and maintain a comprehensive health care database for the purpose of health planning and for certificate-of-need determinations. The agency or its contractor is authorized to require the submission of information from health facilities, health service providers, and licensed health professionals which is determined by the agency, through rule, to be necessary for meeting the agency’s responsibilities as established in this section.
(c) The Department of Health shall contract with the local health councils for the services specified in subsection (1). All contract funds shall be distributed according to an allocation plan developed by the department. The department may withhold funds from a local health council or cancel its contract with a local health council which does not meet performance standards agreed upon by the department and local health councils.
History.—s. 20, ch. 87-92; s. 40, ch. 88-380; s. 35, ch. 88-394; s. 1, ch. 89-104; s. 24, ch. 89-294; s. 2, ch. 89-296; s. 15, ch. 89-527; s. 2, ch. 91-48; s. 22, ch. 91-158; ss. 2, 104, ch. 91-282; s. 5, ch. 91-429; ss. 15, 17, ch. 92-33; s. 2, ch. 92-174; s. 66, ch. 92-289; s. 22, ch. 93-120; s. 11, ch. 93-129; s. 33, ch. 93-206; s. 8, ch. 93-267; s. 9, ch. 95-144; s. 29, ch. 95-210; s. 3, ch. 95-394; s. 11, ch. 97-79; s. 1, ch. 97-91; s. 35, ch. 97-103; s. 62, ch. 97-237; s. 175, ch. 99-8; s. 4, ch. 2000-256; s. 5, ch. 2000-318; s. 3, ch. 2004-383; s. 75, ch. 2006-197; s. 114, ch. 2010-102.
Note.—Former s. 381.703.
408.034 Duties and responsibilities of agency; rules.—
(1) The agency is designated as the single state agency to issue, revoke, or deny certificates of need and to issue, revoke, or deny exemptions from certificate-of-need review in accordance with present and future federal and state statutes. The agency is designated as the state health planning agency for purposes of federal law.
(2) In the exercise of its authority to issue licenses to health care facilities and health service providers, as provided under chapters 393 and 395 and parts II and IV of chapter 400, the agency may not issue a license to any health care facility or health service provider that fails to receive a certificate of need or an exemption for the licensed facility or service.
(3) The agency shall establish, by rule, uniform need methodologies for health services and health facilities. In developing uniform need methodologies, the agency shall, at a minimum, consider the demographic characteristics of the population, the health status of the population, service use patterns, standards and trends, geographic accessibility, and market economics.
(4) Prior to determining that there is a need for additional community nursing facility beds in any area of the state, the agency shall determine that the need cannot be met through the provision, enhancement, or expansion of home and community-based services. In determining such need, the agency shall examine nursing home placement patterns and demographic patterns of persons entering nursing homes and the availability of and effectiveness of existing home-based and community-based service delivery systems at meeting the long-term care needs of the population. The agency shall recommend to the Legislature changes that could be made to existing home-based and community-based delivery systems to lessen the need for additional nursing facility beds.
(5) The agency shall establish by rule a nursing-home-bed-need methodology that has a goal of maintaining a subdistrict average occupancy rate of 94 percent and that reduces the community nursing home bed need for the areas of the state where the agency establishes pilot community diversion programs through the Title XIX aging waiver program.
(6) The agency may adopt rules necessary to implement ss. 408.031-408.045.
History.—s. 21, ch. 87-92; s. 8, ch. 89-354; s. 1, ch. 91-263; s. 15, ch. 92-33; s. 18, ch. 93-214; s. 10, ch. 95-144; s. 2, ch. 98-85; s. 5, ch. 2000-256; s. 6, ch. 2000-318; s. 13, ch. 2002-223; s. 9, ch. 2004-298; s. 4, ch. 2004-383; s. 3, ch. 2005-60; s. 76, ch. 2006-197.
Note.—Former s. 381.704.
408.035 Review criteria.—
(1) The agency shall determine the reviewability of applications and shall review applications for certificate-of-need determinations for health care facilities and health services in context with the following criteria, except for general hospitals as defined in s. 395.002:
(a) The need for the health care facilities and health services being proposed.
(b) The availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant.
(c) The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care.
(d) The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation.
(e) The extent to which the proposed services will enhance access to health care for residents of the service district.
(f) The immediate and long-term financial feasibility of the proposal.
(g) The extent to which the proposal will foster competition that promotes quality and cost-effectiveness.
(h) The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction.
(i) The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent.
(j) The applicant’s designation as a Gold Seal Program nursing facility pursuant to s. 400.235, when the applicant is requesting additional nursing home beds at that facility.
(2) For a general hospital, the agency shall consider only the criteria specified in paragraph (1)(a), paragraph (1)(b), except for quality of care in paragraph (1)(b), and paragraphs (1)(e), (g), and (i).
History.—s. 22, ch. 87-92; s. 20, ch. 88-294; s. 15, ch. 92-33; ss. 37, 50, ch. 93-217; s. 30, ch. 95-210; s. 36, ch. 97-103; s. 39, ch. 97-264; s. 2, ch. 97-270; s. 20, ch. 99-394; s. 6, ch. 2000-256; s. 7, ch. 2000-318; s. 5, ch. 2004-383; s. 1, ch. 2008-29.
Note.—Former s. 381.705.
408.036 Projects subject to review; exemptions.—
(1) APPLICABILITY.—Unless exempt under subsection (3), all health-care-related projects, as described in paragraphs (a)-(g), are subject to review and must file an application for a certificate of need with the agency. The agency is exclusively responsible for determining whether a health-care-related project is subject to review under ss. 408.031-408.045.
(a) The addition of beds in community nursing homes or intermediate care facilities for the developmentally disabled by new construction or alteration.
(b) The new construction or establishment of additional health care facilities, including a replacement health care facility when the proposed project site is not located on the same site as or within 1 mile of the existing health care facility, if the number of beds in each licensed bed category will not increase.
(c) The conversion from one type of health care facility to another, including the conversion from a general hospital, a specialty hospital, or a long-term care hospital.
(d) The establishment of a hospice or hospice inpatient facility, except as provided in s. 408.043.
(e) An increase in the number of beds for comprehensive rehabilitation.
(f) The establishment of tertiary health services, including inpatient comprehensive rehabilitation services.
(2) PROJECTS SUBJECT TO EXPEDITED REVIEW.—Unless exempt pursuant to subsection (3), projects subject to an expedited review shall include, but not be limited to:
(a) A transfer of a certificate of need, except that when an existing hospital is acquired by a purchaser, all certificates of need issued to the hospital which are not yet operational shall be acquired by the purchaser, without need for a transfer.
(b) Replacement of a nursing home within the same district, if the proposed project site is located within a geographic area that contains at least 65 percent of the facility’s current residents and is within a 30-mile radius of the replaced nursing home.
(c) Relocation of a portion of a nursing home’s licensed beds to a facility within the same district, if the relocation is within a 30-mile radius of the existing facility and the total number of nursing home beds in the district does not increase.
The agency shall develop rules to implement the provisions for expedited review, including time schedule, application content which may be reduced from the full requirements of s. 408.037(1), and application processing.
(3) EXEMPTIONS.—Upon request, the following projects are subject to exemption from the provisions of subsection (1):
(a) For hospice services or for swing beds in a rural hospital, as defined in s. 395.602, in a number that does not exceed one-half of its licensed beds.
(b) For the conversion of licensed acute care hospital beds to Medicare and Medicaid certified skilled nursing beds in a rural hospital, as defined in s. 395.602, so long as the conversion of the beds does not involve the construction of new facilities. The total number of skilled nursing beds, including swing beds, may not exceed one-half of the total number of licensed beds in the rural hospital as of July 1, 1993. Certified skilled nursing beds designated under this paragraph, excluding swing beds, shall be included in the community nursing home bed inventory. A rural hospital that subsequently decertifies any acute care beds exempted under this paragraph shall notify the agency of the decertification, and the agency shall adjust the community nursing home bed inventory accordingly.
(c) For the addition of nursing home beds at a skilled nursing facility that is part of a retirement community that provides a variety of residential settings and supportive services and that has been incorporated and operated in this state for at least 65 years on or before July 1, 1994. All nursing home beds must not be available to the public but must be for the exclusive use of the community residents.
(d) For an inmate health care facility built by or for the exclusive use of the Department of Corrections as provided in chapter 945. This exemption expires when such facility is converted to other uses.
(e) For mobile surgical facilities and related health care services provided under contract with the Department of Corrections or a private correctional facility operating pursuant to chapter 957.
(f) For the creation of a single nursing home within a district by combining licensed beds from two or more licensed nursing homes within such district, regardless of subdistrict boundaries, if 50 percent of the beds in the created nursing home are transferred from the only nursing home in a county and its utilization data demonstrate that it had an occupancy rate of less than 75 percent for the 12-month period ending 90 days before the request for the exemption. This paragraph is repealed upon the expiration of the moratorium established in s. 408.0435(1).
(g) For state veterans’ nursing homes operated by or on behalf of the Florida Department of Veterans’ Affairs in accordance with part II of chapter 296 for which at least 50 percent of the construction cost is federally funded and for which the Federal Government pays a per diem rate not to exceed one-half of the cost of the veterans’ care in such state nursing homes. These beds shall not be included in the nursing home bed inventory.
(h) For combination within one nursing home facility of the beds or services authorized by two or more certificates of need issued in the same planning subdistrict. An exemption granted under this paragraph shall extend the validity period of the certificates of need to be consolidated by the length of the period beginning upon submission of the exemption request and ending with issuance of the exemption. The longest validity period among the certificates shall be applicable to each of the combined certificates.
(i) For division into two or more nursing home facilities of beds or services authorized by one certificate of need issued in the same planning subdistrict. An exemption granted under this paragraph shall extend the validity period of the certificate of need to be divided by the length of the period beginning upon submission of the exemption request and ending with issuance of the exemption.
(j) For the addition of hospital beds licensed under chapter 395 for comprehensive rehabilitation in a number that may not exceed 10 total beds or 10 percent of the licensed capacity, whichever is greater.
1. In addition to any other documentation otherwise required by the agency, a request for exemption submitted under this paragraph must:
a. Certify that the prior 12-month average occupancy rate for the licensed beds being expanded meets or exceeds 80 percent.
b. Certify that the beds have been licensed and operational for at least 12 months.
2. The timeframes and monitoring process specified in s. 408.040(2)(a)-(c) apply to any exemption issued under this paragraph.
3. The agency shall count beds authorized under this paragraph as approved beds in the published inventory of hospital beds until the beds are licensed.
(k) For the addition of nursing home beds licensed under chapter 400 in a number not exceeding 10 total beds or 10 percent of the number of beds licensed in the facility being expanded, whichever is greater; or, for the addition of nursing home beds licensed under chapter 400 at a facility that has been designated as a Gold Seal nursing home under s. 400.235 in a number not exceeding 20 total beds or 10 percent of the number of licensed beds in the facility being expanded, whichever is greater.
1. In addition to any other documentation required by the agency, a request for exemption submitted under this paragraph must:
a. Certify that the facility has not had any class I or class II deficiencies within the 30 months preceding the request for addition.
b. Certify that the prior 12-month average occupancy rate for the nursing home beds at the facility meets or exceeds 96 percent.
c. Certify that any beds authorized for the facility under this paragraph before the date of the current request for an exemption have been licensed and operational for at least 12 months.
2. The timeframes and monitoring process specified in s. 408.040(2)(a)-(c) apply to any exemption issued under this paragraph.
3. The agency shall count beds authorized under this paragraph as approved beds in the published inventory of nursing home beds until the beds are licensed.
(l) For the establishment of:
1. A Level II neonatal intensive care unit with at least 10 beds, upon documentation to the agency that the applicant hospital had a minimum of 1,500 births during the previous 12 months;
2. A Level III neonatal intensive care unit with at least 15 beds, upon documentation to the agency that the applicant hospital has a Level II neonatal intensive care unit of at least 10 beds and had a minimum of 3,500 births during the previous 12 months; or
3. A Level III neonatal intensive care unit with at least 5 beds, upon documentation to the agency that the applicant hospital is a verified trauma center pursuant to s. 395.4001(14), and has a Level II neonatal intensive care unit,
if the applicant demonstrates that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in agency certificate-of-need rules for Level II and Level III neonatal intensive care units and if the applicant commits to the provision of services to Medicaid and charity patients at a level equal to or greater than the district average. Such a commitment is subject to s. 408.040.
(m)1. For the provision of adult open-heart services in a hospital located within the boundaries of a health service planning district, as defined in s. 408.032(5), which has experienced an annual net out-migration of at least 600 open-heart-surgery cases for 3 consecutive years according to the most recent data reported to the agency, and the district’s population per licensed and operational open-heart programs exceeds the state average of population per licensed and operational open-heart programs by at least 25 percent. All hospitals within a health service planning district which meet the criteria reference in sub-subparagraphs 2.a.-h. shall be eligible for this exemption on July 1, 2004, and shall receive the exemption upon filing for it and subject to the following:
a. A hospital that has received a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for the establishment of an open-heart-surgery program is entitled to receive a letter of exemption for the establishment of an adult open-heart-surgery program upon filing a request for exemption and complying with the criteria enumerated in sub-subparagraphs 2.a.-h., and is entitled to immediately commence operation of the program.
b. An otherwise eligible hospital that has not received a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for the establishment of an open-heart-surgery program is entitled to immediately receive a letter of exemption for the establishment of an adult open-heart-surgery program upon filing a request for exemption and complying with the criteria enumerated in sub-subparagraphs 2.a.-h., but is not entitled to commence operation of its program until December 31, 2006.
2. A hospital shall be exempt from the certificate-of-need review for the establishment of an open-heart-surgery program when the application for exemption submitted under this paragraph complies with the following criteria:
a. The applicant must certify that it will meet and continuously maintain the minimum licensure requirements adopted by the agency governing adult open-heart programs, including the most current guidelines of the American College of Cardiology and American Heart Association Guidelines for Adult Open Heart Programs.
b. The applicant must certify that it will maintain sufficient appropriate equipment and health personnel to ensure quality and safety.
c. The applicant must certify that it will maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies.
d. The applicant can demonstrate that it has discharged at least 300 inpatients with a principal diagnosis of ischemic heart disease for the most recent 12-month period as reported to the agency.
e. The applicant is a general acute care hospital that is in operation for 3 years or more.
f. The applicant is performing more than 300 diagnostic cardiac catheterization procedures per year, combined inpatient and outpatient.
g. The applicant’s payor mix at a minimum reflects the community average for Medicaid, charity care, and self-pay patients or the applicant must certify that it will provide a minimum of 5 percent of Medicaid, charity care, and self-pay to open-heart-surgery patients.
h. If the applicant fails to meet the established criteria for open-heart programs or fails to reach 300 surgeries per year by the end of its third year of operation, it must show cause why its exemption should not be revoked.
3. By December 31, 2004, and annually thereafter, the agency shall submit a report to the Legislature providing information concerning the number of requests for exemption it has received under this paragraph during the calendar year and the number of exemptions it has granted or denied during the calendar year.
(n) For the provision of percutaneous coronary intervention for patients presenting with emergency myocardial infarctions in a hospital without an approved adult open-heart-surgery program. In addition to any other documentation required by the agency, a request for an exemption submitted under this paragraph must comply with the following:
1. The applicant must certify that it will meet and continuously maintain the requirements adopted by the agency for the provision of these services. These licensure requirements shall be adopted by rule pursuant to ss. 120.536(1) and 120.54 and must be consistent with the guidelines published by the American College of Cardiology and the American Heart Association for the provision of percutaneous coronary interventions in hospitals without adult open-heart services. At a minimum, the rules shall require the following:
a. Cardiologists must be experienced interventionalists who have performed a minimum of 75 interventions within the previous 12 months.
b. The hospital must provide a minimum of 36 emergency interventions annually in order to continue to provide the service.
c. The hospital must offer sufficient physician, nursing, and laboratory staff to provide the services 24 hours a day, 7 days a week.
d. Nursing and technical staff must have demonstrated experience in handling acutely ill patients requiring intervention based on previous experience in dedicated interventional laboratories or surgical centers.
e. Cardiac care nursing staff must be adept in hemodynamic monitoring and Intra-aortic Balloon Pump (IABP) management.
f. Formalized written transfer agreements must be developed with a hospital with an adult open-heart-surgery program, and written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer and transport agreements must be 1reviewed and tested, with appropriate documentation maintained at least every 3 months.
g. Hospitals implementing the service must first undertake a training program of 3 to 6 months’ duration, which includes establishing standards and testing logistics, creating quality assessment and error management practices, and formalizing patient-selection criteria.
2. The applicant must certify that it will use at all times the patient-selection criteria for the performance of primary angioplasty at hospitals without adult open-heart-surgery programs issued by the American College of Cardiology and the American Heart Association. At a minimum, these criteria would provide for the following:
a. Avoidance of interventions in hemodynamically stable patients who have identified symptoms or medical histories.
b. Transfer of patients who have a history of coronary disease and clinical presentation of hemodynamic instability.
3. The applicant must agree to submit a quarterly report to the agency detailing patient characteristics, treatment, and outcomes for all patients receiving emergency percutaneous coronary interventions pursuant to this paragraph. This report must be submitted within 15 days after the close of each calendar quarter.
4. The exemption provided by this paragraph does not apply unless the agency determines that the hospital has taken all necessary steps to be in compliance with all requirements of this paragraph, including the training program required under sub-subparagraph 1.g.
5. Failure of the hospital to continuously comply with the requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2. and 3. will result in the immediate expiration of this exemption.
6. Failure of the hospital to meet the volume requirements of sub-subparagraphs 1.a. and b. within 18 months after the program begins offering the service will result in the immediate expiration of the exemption.
If the exemption for this service expires under subparagraph 5. or subparagraph 6., the agency may not grant another exemption for this service to the same hospital for 2 years and then only upon a showing that the hospital will remain in compliance with the requirements of this paragraph through a demonstration of corrections to the deficiencies that caused expiration of the exemption. Compliance with the requirements of this paragraph includes compliance with the rules adopted pursuant to this paragraph.
(o) For the addition of mental health services or beds if the applicant commits to providing services to Medicaid or charity care patients at a level equal to or greater than the district average. Such a commitment is subject to s. 408.040.
(p) For replacement of a licensed nursing home on the same site, or within 3 miles of the same site, if the number of licensed beds does not increase.
(q) For consolidation or combination of licensed nursing homes or transfer of beds between licensed nursing homes within the same planning subdistrict, by providers that operate multiple nursing homes within that planning subdistrict, if there is no increase in the planning subdistrict total number of nursing home beds and the site of the relocation is not more than 30 miles from the original location.
(r) For beds in state mental health treatment facilities defined in s. 394.455 and state mental health forensic facilities operated under chapter 916.
(s) For beds in state developmental disabilities centers as defined in s. 393.063.
(4) REQUESTS FOR EXEMPTION.—A request for exemption under subsection (3) may be made at any time and is not subject to the batching requirements of this section. The request shall be supported by such documentation as the agency requires by rule. The agency shall assess a fee of $250 for each request for exemption submitted under subsection (3).
(5) NOTIFICATION.—Health care facilities and providers must provide to the agency notification of:
(a) Replacement of a health care facility when the proposed project site is located in the same district and on the existing site or within a 1-mile radius of the replaced health care facility, if the number and type of beds do not increase.
(b) The termination of a health care service, upon 30 days’ written notice to the agency.
(c) The addition or delicensure of beds.
Notification under this subsection may be made by electronic, facsimile, or written means at any time before the described action has been taken.
History.—s. 23, ch. 87-92; s. 21, ch. 88-294; s. 2, ch. 89-527; ss. 3, 16, ch. 91-282; s. 15, ch. 92-33; s. 67, ch. 92-289; s. 30, ch. 93-129; s. 19, ch. 93-214; s. 38, ch. 93-217; ss. 3, 4, ch. 94-206; s. 58, ch. 95-144; s. 143, ch. 95-418; s. 3, ch. 97-270; s. 4, ch. 97-290; s. 3, ch. 98-14; s. 22, ch. 98-80; s. 3, ch. 98-85; s. 8, ch. 98-303; s. 7, ch. 2000-256; s. 15, ch. 2000-305; s. 8, ch. 2000-318; s. 15, ch. 2001-104; s. 13, ch. 2003-2; s. 1, ch. 2003-274; s. 1, ch. 2003-289; s. 10, ch. 2004-298; s. 1, ch. 2004-382; s. 6, ch. 2004-383; s. 2, ch. 2006-161; s. 8, ch. 2006-192; s. 26, ch. 2006-195; s. 51, ch. 2006-227; s. 88, ch. 2007-5; s. 15, ch. 2008-244; s. 11, ch. 2009-20; s. 19, ch. 2010-4; s. 1, ch. 2011-195.
1Note.—As amended by s. 1, ch. 2004-382. The amendment by s. 6, ch. 2004-383, used “received” instead of “reviewed.”
Note.—Former s. 381.706.
408.0361 Cardiovascular services and burn unit licensure.—
(1) Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs:
(a) Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories.
(b) Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services.
(c) Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety.
(d) Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies.
(e) Demonstrate a plan to provide services to Medicaid and charity care patients.
(2) Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period.
(3) In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for:
(a) Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery.
(b) For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes.
(c) For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease.
(d) Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.
(e) Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies.
(f) Demonstration of a plan to provide services to Medicaid and charity care patients.
(4) In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12-month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license.
(5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following:
1. A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state.
2. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery.
3. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans.
(b) Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons.
History.—s. 5, ch. 99-356; s. 48, ch. 2001-62; s. 2, ch. 2004-382; s. 7, ch. 2004-383; s. 1, ch. 2007-214; s. 2, ch. 2007-248; s. 88, ch. 2010-5.
408.037 Application content.—
(1) Except as provided in subsection (2) for a general hospital, an application for a certificate of need must contain:
(a) A detailed description of the proposed project and statement of its purpose and need in relation to the district health plan.
(b) A statement of the financial resources needed by and available to the applicant to accomplish the proposed project. This statement must include:
1. A complete listing of all capital projects, including new health facility development projects and health facility acquisitions applied for, pending, approved, or underway in any state at the time of application, regardless of whether or not that state has a certificate-of-need program or a capital expenditure review program pursuant to s. 1122 of the Social Security Act. The agency may, by rule, require less-detailed information from major health care providers. This listing must include the applicant’s actual or proposed financial commitment to those projects and an assessment of their impact on the applicant’s ability to provide the proposed project.
2. A detailed listing of the needed capital expenditures, including sources of funds.
3. A detailed financial projection, including a statement of the projected revenue and expenses for the first 2 years of operation after completion of the proposed project. This statement must include a detailed evaluation of the impact of the proposed project on the cost of other services provided by the applicant.
(c) An audited financial statement of the applicant. In an application submitted by an existing health care facility, health maintenance organization, or hospice, financial condition documentation must include, but need not be limited to, a balance sheet and a profit-and-loss statement of the 2 previous fiscal years’ operation.
(2) An application for a certificate of need for a general hospital must contain a detailed description of the proposed general hospital project and a statement of its purpose and the needs it will meet. The proposed project’s location, as well as its primary and secondary service areas, must be identified by zip code. Primary service area is defined as the zip codes from which the applicant projects that it will draw 75 percent of its discharges. Secondary service area is defined as the zip codes from which the applicant projects that it will draw its remaining discharges. If, subsequent to issuance of a final order approving the certificate of need, the proposed location of the general hospital changes or the primary service area materially changes, the agency shall revoke the certificate of need. However, if the agency determines that such changes are deemed to enhance access to hospital services in the service district, the agency may permit such changes to occur. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital has standing to participate in any subsequent proceeding regarding the revocation of the certificate of need for a hospital for which the location has changed or for which the primary service area has materially changed. In addition, the application for the certificate of need for a general hospital must include a statement of intent that, if approved by final order of the agency, the applicant shall within 120 days after issuance of the final order or, if there is an appeal of the final order, within 120 days after the issuance of the court’s mandate on appeal, furnish satisfactory proof of the applicant’s financial ability to operate. The agency shall establish documentation requirements, to be completed by each applicant, which show anticipated provider revenues and expenditures, the basis for financing the anticipated cash-flow requirements of the provider, and an applicant’s access to contingency financing. A party participating in the administrative hearing regarding the issuance of the certificate of need for a general hospital may provide written comments concerning the adequacy of the financial information provided, but such party does not have standing to participate in an administrative proceeding regarding proof of the applicant’s financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider.
(3) The applicant must certify that it will license and operate the health care facility. For an existing health care facility, the applicant must be the licenseholder of the facility.
History.—s. 24, ch. 87-92; s. 15, ch. 92-33; s. 4, ch. 97-270; s. 8, ch. 2000-256; s. 9, ch. 2000-318; s. 2, ch. 2008-29.
Note.—Former s. 381.707.
408.038 Fees.—The agency shall assess fees on certificate-of-need applications. Such fees shall be for the purpose of funding the activities of the agency and shall be allocated as provided in s. 408.033. The fee shall be determined as follows:
(1) A minimum base fee of $10,000.
(2) In addition to the base fee of $10,000, 0.015 of each dollar of proposed expenditure, except that a fee may not exceed $50,000.
History.—s. 25, ch. 87-92; s. 2, ch. 89-104; s. 16, ch. 89-527; s. 4, ch. 91-282; s. 15, ch. 92-33; s. 11, ch. 95-144; s. 17, ch. 97-79; s. 9, ch. 2000-256; s. 10, ch. 2000-318; s. 8, ch. 2004-383.
Note.—Former s. 381.708.
408.039 Review process.—The review process for certificates of need shall be as follows:
(1) REVIEW CYCLES.—The agency by rule shall provide for applications to be submitted on a timetable or cycle basis; provide for review on a timely basis; and provide for all completed applications pertaining to similar types of services or facilities affecting the same service district to be considered in relation to each other no less often than annually.
(2) LETTERS OF INTENT.—
(a) At least 30 days prior to filing an application, a letter of intent shall be filed by the applicant with the agency, respecting the development of a proposal subject to review. No letter of intent is required for expedited projects as defined by rule by the agency.
(b) The agency shall provide a mechanism by which applications may be filed to compete with proposals described in filed letters of intent.
(c) Letters of intent must describe the proposal; specify the number of beds sought, if any; identify the services to be provided and the specific subdistrict location; and identify the applicant.
(d) Within 21 days after filing a letter of intent, the agency shall publish notice of the filing of letters of intent in the Florida Administrative Weekly and notice that, if requested, a public hearing shall be held at the local level within 21 days after the application is deemed complete. Notices under this paragraph must contain due dates applicable to the cycle for filing applications and for requesting a hearing.
(3) APPLICATION PROCESSING.—
(a) An applicant shall file an application with the agency and shall furnish a copy of the application to the agency. Within 15 days after the applicable application filing deadline established by agency rule, the staff of the agency shall determine if the application is complete. If the application is incomplete, the staff shall request specific information from the applicant necessary for the application to be complete; however, the staff may make only one such request. If the requested information is not filed with the agency within 21 days after the receipt of the staff’s request, the application shall be deemed incomplete and deemed withdrawn from consideration.
(b) Upon the request of any applicant or substantially affected person within 14 days after notice that an application has been filed, a public hearing may be held at the agency’s discretion if the agency determines that a proposed project involves issues of great local public interest. In such cases, the agency shall attend the public hearing. The public hearing shall allow applicants and other interested parties reasonable time to present their positions and to present rebuttal information. A recorded verbatim record of the hearing shall be maintained. The public hearing shall be held at the local level within 21 days after the application is deemed complete.
(c) Except for competing applicants, in order to be eligible to challenge the agency decision on a general hospital application under review pursuant to paragraph (5)(c), existing hospitals must submit a detailed written statement of opposition to the agency and to the applicant. The detailed written statement must be received by the agency and the applicant within 21 days after the general hospital application is deemed complete and made available to the public.
(d) In those cases where a written statement of opposition has been timely filed regarding a certificate of need application for a general hospital, the applicant for the general hospital may submit a written response to the agency. Such response must be received by the agency within 10 days of the written statement due date.
(4) STAFF RECOMMENDATIONS.—
(a) The agency’s review of and final agency action on applications shall be in accordance with statutory criteria and the implementing administrative rules. In the application review process, the agency shall give a preference, as defined by rule of the agency, to an applicant which proposes to develop a nursing home in a nursing home geographically underserved area.
(b) Within 60 days after all the applications in a review cycle are determined to be complete, the agency shall issue its State Agency Action Report and Notice of Intent to grant a certificate of need for the project in its entirety, to grant a certificate of need for identifiable portions of the project, or to deny a certificate of need. The State Agency Action Report shall set forth in writing its findings of fact and determinations upon which its decision is based. If the agency intends to grant a certificate of need, the State Agency Action Report or the Notice of Intent shall also include any conditions which the agency intends to attach to the certificate of need. The agency shall designate by rule a senior staff person, other than the person who issues the final order, to issue State Agency Action Reports and Notices of Intent.
(c) The agency shall publish its proposed decision set forth in the Notice of Intent in the Florida Administrative Weekly within 14 days after the Notice of Intent is issued.
(d) If no administrative hearing is requested pursuant to subsection (5), the State Agency Action Report and the Notice of Intent shall become the final order of the agency. The agency shall provide a copy of the final order to the appropriate local health council.
(5) ADMINISTRATIVE HEARINGS.—
(a) Within 21 days after publication of notice of the State Agency Action Report and Notice of Intent, any person authorized under paragraph (c) to participate in a hearing may file a request for an administrative hearing; failure to file a request for hearing within 21 days of publication of notice shall constitute a waiver of any right to a hearing and a waiver of the right to contest the final decision of the agency. A copy of the request for hearing shall be served on the applicant.
(b) Hearings shall be held in Tallahassee unless the administrative law judge determines that changing the location will facilitate the proceedings. The agency shall assign proceedings requiring hearings to the Division of Administrative Hearings of the Department of Management Services within 10 days after the time has expired for requesting a hearing. Except upon unanimous consent of the parties or upon the granting by the administrative law judge of a motion of continuance, hearings shall commence within 60 days after the administrative law judge has been assigned. For an application for a general hospital, administrative hearings shall commence within 6 months after the administrative law judge has been assigned, and a continuance may not be granted absent a finding of extraordinary circumstances by the administrative law judge. All parties, except the agency, shall bear their own expense of preparing a transcript. In any application for a certificate of need which is referred to the Division of Administrative Hearings for hearing, the administrative law judge shall complete and submit to the parties a recommended order as provided in ss. 120.569 and 120.57. The recommended order shall be issued within 30 days after the receipt of the proposed recommended orders or the deadline for submission of such proposed recommended orders, whichever is earlier. The division shall adopt procedures for administrative hearings which shall maximize the use of stipulated facts and shall provide for the admission of prepared testimony.
(c) In administrative proceedings challenging the issuance or denial of a certificate of need, only applicants considered by the agency in the same batching cycle are entitled to a comparative hearing on their applications. Existing health care facilities may initiate or intervene in an administrative hearing upon a showing that an established program will be substantially affected by the issuance of any certificate of need, whether reviewed under s. 408.036(1) or (2), to a competing proposed facility or program within the same district. With respect to an application for a general hospital, competing applicants and only those existing hospitals that submitted a detailed written statement of opposition to an application as provided in this paragraph may initiate or intervene in an administrative hearing. Such challenges to a general hospital application shall be limited in scope to the issues raised in the detailed written statement of opposition that was provided to the agency. The administrative law judge may, upon a motion showing good cause, expand the scope of the issues to be heard at the hearing. Such motion shall include substantial and detailed facts and reasons for failure to include such issues in the original written statement of opposition.
(d) The applicant’s failure to strictly comply with the requirements of s. 408.037(1) or paragraph (2)(c) is not cause for dismissal of the application, unless the failure to comply impairs the fairness of the proceeding or affects the correctness of the action taken by the agency.
(e) The agency shall issue its final order within 45 days after receipt of the recommended order. If the agency fails to take action within such time, or as otherwise agreed to by the applicant and the agency, the applicant may take appropriate legal action to compel the agency to act. When making a determination on an application for a certificate of need, the agency is specifically exempt from the time limitations provided in s. 120.60(1).
(6) JUDICIAL REVIEW.—
(a) A party to an administrative hearing for an application for a certificate of need has the right, within not more than 30 days after the date of the final order, to seek judicial review in the District Court of Appeal pursuant to s. 120.68. The agency shall be a party in any such proceeding.
(b) In such judicial review, the court shall affirm the final order of the agency, unless the decision is arbitrary, capricious, or not in compliance with ss. 408.031-408.045.
(c) The court, in its discretion, may award reasonable attorney’s fees and costs to the prevailing party if the court finds that there was a complete absence of a justiciable issue of law or fact raised by the losing party.
(d) The party appealing a final order that grants a general hospital certificate of need shall pay the appellee’s attorney’s fees and costs, in an amount up to $1 million, from the beginning of the original administrative action if the appealing party loses the appeal, subject to the following limitations and requirements:
1. The party appealing a final order must post a bond in the amount of $1 million in order to maintain the appeal.
2. Except as provided under s. 120.595(5), in no event shall the agency be held liable for any other party’s attorney’s fees or costs.
History.—s. 26, ch. 87-92; s. 9, ch. 89-354; s. 15, ch. 92-33; s. 125, ch. 92-279; s. 55, ch. 92-326; s. 12, ch. 95-144; s. 190, ch. 96-410; s. 18, ch. 97-79; s. 5, ch. 97-270; s. 10, ch. 2000-256; s. 11, ch. 2000-318; s. 9, ch. 2004-383; s. 3, ch. 2008-29.
Note.—Former s. 381.709.
408.040 Conditions and monitoring.—
(1)(a) The agency may issue a certificate of need, or an exemption, predicated upon statements of intent expressed by an applicant in the application for a certificate of need or an exemption. Any conditions imposed on a certificate of need or an exemption based on such statements of intent shall be stated on the face of the certificate of need or in the exemption approval.
(b) The agency may consider, in addition to the other criteria specified in s. 408.035, a statement of intent by the applicant that a specified percentage of the annual patient days at the facility will be utilized by patients eligible for care under Title XIX of the Social Security Act. Any certificate of need issued to a nursing home in reliance upon an applicant’s statements that a specified percentage of annual patient days will be utilized by residents eligible for care under Title XIX of the Social Security Act must include a statement that such certification is a condition of issuance of the certificate of need. The certificate-of-need program shall notify the Medicaid program office and the Department of Elderly Affairs when it imposes conditions as authorized in this paragraph in an area in which a community diversion pilot project is implemented. Effective July 1, 2012, the agency may not impose sanctions related to patient day utilization by patients eligible for care under Title XIX of the Social Security Act for nursing homes.
(c) A certificateholder or an exemption holder may apply to the agency for a modification of conditions imposed under paragraph (a) or paragraph (b). If the holder of a certificate of need or an exemption demonstrates good cause why the certificate or exemption should be modified, the agency shall reissue the certificate of need or exemption with such modifications as may be appropriate. The agency shall by rule define the factors constituting good cause for modification.
(d) If the holder of a certificate of need or an exemption fails to comply with a condition upon which the issuance of the certificate or exemption was predicated, the agency may assess an administrative fine against the certificateholder or exemption holder in an amount not to exceed $1,000 per failure per day. Failure to annually report compliance with any condition upon which the issuance of the certificate or exemption was predicated constitutes noncompliance. In assessing the penalty, the agency shall take into account as mitigation the degree of noncompliance. Proceeds of such penalties shall be deposited in the Public Medical Assistance Trust Fund.
(2)1(a) Unless the applicant has commenced construction, if the project provides for construction, unless the applicant has incurred an enforceable capital expenditure commitment for a project, if the project does not provide for construction, or unless subject to paragraph (b), a certificate of need shall terminate 18 months after the date of issuance, except a certificate of need of an entity which was issued on or before April 1, 2009, shall terminate 36 months after the date of issuance. The agency shall monitor the progress of the holder of the certificate of need in meeting the timetable for project development specified in the application, and may revoke the certificate of need, if the holder of the certificate is not meeting such timetable and is not making a good-faith effort, as defined by rule, to meet it.
(b) A certificate of need issued to an applicant holding a provisional certificate of authority under chapter 651 shall terminate 1 year after the applicant receives a valid certificate of authority from the Office of Insurance Regulation of the Financial Services Commission.
(c) The certificate-of-need validity period for a project shall be extended by the agency, to the extent that the applicant demonstrates to the satisfaction of the agency that good-faith commencement of the project is being delayed by litigation or by governmental action or inaction with respect to regulations or permitting precluding commencement of the project.
History.—s. 27, ch. 87-92; s. 22, ch. 88-294; s. 15, ch. 92-33; s. 13, ch. 95-144; s. 6, ch. 97-270; s. 4, ch. 98-85; s. 11, ch. 2000-256; s. 12, ch. 2000-318; s. 434, ch. 2003-261; s. 10, ch. 2004-383; s. 3, ch. 2006-161; s. 2, ch. 2007-82; s. 4, ch. 2008-29; s. 1, ch. 2009-45; s. 14, ch. 2009-223; s. 3, ch. 2011-135.
1Note.—As amended by s. 14, ch. 2009-223. For a description of multiple acts in the same session affecting a statutory provision, see preface to the Florida Statutes, “Statutory Construction.” Paragraph (2)(a) was also amended by s. 1, ch. 2009-45, and that version reads:
(2)(a) Unless the applicant has commenced construction, if the project provides for construction, unless the applicant has incurred an enforceable capital expenditure commitment for a project, if the project does not provide for construction, or unless subject to paragraph (b), a certificate of need shall terminate 3 years after the date of issuance. The agency shall monitor the progress of the holder of the certificate of need in meeting the timetable for project development specified in the application, and may revoke the certificate of need, if the holder of the certificate is not meeting such timetable and is not making a good-faith effort, as defined by rule, to meet it.
Note.—Former s. 381.710.
408.041 Certificate of need required; penalties.—It is unlawful for any person to undertake a project subject to review under ss. 408.031-408.045 without a valid certificate of need. Any person violating the provisions of this section is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Each day of continuing violation shall be considered a separate offense.
History.—s. 28, ch. 87-92; s. 62, ch. 91-224; s. 15, ch. 92-33; s. 14, ch. 95-144.
Note.—Former s. 381.711.
408.042 Limitation on transfer.—The holder of a certificate of need shall not charge a price for the transfer of the certificate of need to another person that exceeds the total amount of the actual costs incurred by the holder in obtaining the certificate of need. Such actual costs must be documented by an affidavit executed by the transferor under oath. A holder who violates this section is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082, or by a fine not exceeding $10,000, or both.
History.—s. 29, ch. 87-92; s. 15, ch. 92-33; s. 7, ch. 97-270.
Note.—Former s. 381.712.
408.043 Special provisions.—
(1) OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application is made for a certificate of need to construct or to expand an osteopathic acute care hospital, the need for such hospital shall be determined on the basis of the need for and availability of osteopathic services and osteopathic acute care hospitals in the district. When a prior certificate of need to establish an osteopathic acute care hospital has been issued in a district, and the facility is no longer used for that purpose, the agency may continue to count such facility and beds as an existing osteopathic facility in any subsequent application for construction of an osteopathic acute care hospital.
(2) HOSPICES.—When an application is made for a certificate of need to establish or to expand a hospice, the need for such hospice shall be determined on the basis of the need for and availability of hospice services in the community. The formula on which the certificate of need is based shall discourage regional monopolies and promote competition. The inpatient hospice care component of a hospice which is a freestanding facility, or a part of a facility, which is primarily engaged in providing inpatient care and related services and is not licensed as a health care facility shall also be required to obtain a certificate of need. Provision of hospice care by any current provider of health care is a significant change in service and therefore requires a certificate of need for such services.
(3) RURAL HEALTH NETWORKS.—Preference shall be given in the award of a certificate of need to members of certified rural health networks, as provided for in s. 381.0406, subject to the following conditions:
(a) Need must be shown pursuant to s. 408.035.
(b) The proposed project must:
1. Strengthen health care services in rural areas through partnerships between rural care providers; or
2. Increase access to inpatient health care services for Medicaid recipients or other low-income persons who live in rural areas.
(c) No preference shall be given under this section for the establishment of skilled nursing facility services by a hospital.
(4) PRIVATE ACCREDITATION NOT REQUIRED.—Accreditation by any private organization may not be a requirement for the issuance or maintenance of a certificate of need under ss. 408.031-408.045.
History.—s. 30, ch. 87-92; s. 15, ch. 91-282; s. 15, ch. 92-33; s. 31, ch. 93-129; s. 8, ch. 97-270; s. 1, ch. 2003-161; s. 11, ch. 2004-383.
Note.—Former s. 381.713.
408.0435 Moratorium on nursing home certificates of need.—
(1) Notwithstanding the establishment of need as provided for in this chapter, a certificate of need for additional community nursing home beds may not be approved by the agency until Medicaid managed care is implemented statewide pursuant to ss. 409.961-409.985 or October 1, 2016, whichever is earlier.
(2) The Legislature finds that the continued growth in the Medicaid budget for nursing home care has constrained the ability of the state to meet the needs of its elderly residents through the use of less restrictive and less institutional methods of long-term care. It is therefore the intent of the Legislature to limit the increase in Medicaid nursing home expenditures in order to provide funds to invest in long-term care that is community-based and provides supportive services in a manner that is both more cost-effective and more in keeping with the wishes of the elderly residents of this state.
(3) This moratorium on certificates of need shall not apply to sheltered nursing home beds in a continuing care retirement community certified by the former Department of Insurance or by the Office of Insurance Regulation pursuant to chapter 651.
(4)(a) The moratorium on certificates of need does not apply and a certificate of need for additional community nursing home beds may be approved for a county that meets the following circumstances:
1. The county has no community nursing home beds; and
2. The lack of community nursing home beds occurs because all nursing home beds in the county that were licensed on July 1, 2001, have subsequently closed.
(b) The certificate-of-need review for such circumstances shall be subject to the comparative review process consistent with the provisions of s. 408.039, and the number of beds may not exceed the number of beds lost by the county after July 1, 2001.
This subsection shall be repealed upon the expiration of the moratorium established in subsection (1).
(5) The moratorium on certificates of need does not apply for the addition of nursing home beds licensed under chapter 400 to a nursing home located in a county having up to 50,000 residents, in a number not exceeding 10 total beds or 10 percent of the number of beds licensed in the facility being expanded, whichever is greater. In addition to any other documentation required by the agency, a request submitted under this subsection must:
(a) Certify that the facility has not had any class I or class II deficiencies within the 30 months preceding the request for addition.
(b) Certify that the prior 12-month average occupancy rate for the nursing home beds at the facility meets or exceeds 94 percent and the facility had not had any class I or class II deficiencies since its initial licensure.
(c) For a facility that has been licensed for less than 24 months, certify that the prior 6-month average occupancy rate for the nursing home beds at the facility meets or exceeds 94 percent and that the facility has not had any class I or class II deficiencies since its initial licensure.
This subsection shall be repealed upon the expiration of the moratorium established in subsection (1).
(6) The moratorium on certificates of need does not apply for the addition of nursing home beds licensed under chapter 400 in a number not exceeding 10 total beds or 10 percent of the number of beds licensed in the facility being expanded, whichever is greater, if the facility meets the requirements of paragraph (a).
(a) In addition to any other documentation required by the agency, a request for the addition of beds under this subsection must certify that:
1. The facility has not had any class I or class II deficiencies within the 30 months preceding the request for addition;
2. The prior 12-month average occupancy rate for the nursing home beds at the facility meets or exceeds 96 percent;
3. The occupancy rate for nursing home beds in the subdistrict is 94 percent or greater; and
4. Any beds authorized for the facility under this subsection before the date of the current request for additional beds have been licensed and operational for at least 12 months.
(b) A nursing home may request additional beds under this subsection as an exemption from the provisions of s. 408.036(1). The timeframes and monitoring process specified in s. 408.040(2)(a)-(c) apply to any exemption issued under this subsection.
(c) The agency shall count beds authorized under this subsection as approved beds in the published inventory of nursing home beds until the beds are licensed.
This subsection shall be repealed upon the expiration of the moratorium established in subsection (1).
History.—s. 52, ch. 2001-45; s. 1693, ch. 2003-261; s. 12, ch. 2004-298; s. 14, ch. 2004-383; s. 1, ch. 2006-161; s. 4, ch. 2011-135.
Note.—Former s. 651.1185.
408.044 Injunction.—Notwithstanding the existence or pursuit of any other remedy, the agency may maintain an action in the name of the state for injunction or other process against any person to restrain or prevent the pursuit of a project subject to review under ss. 408.031-408.045, in the absence of a valid certificate of need.
History.—s. 31, ch. 87-92; s. 15, ch. 92-33; s. 15, ch. 95-144; s. 12, ch. 2000-256; s. 13, ch. 2000-318.
Note.—Former s. 381.714.
408.045 Certificate of need; competitive sealed proposals.—
(1) The application, review, and issuance procedures for a certificate of need for an intermediate care facility for the developmentally disabled may be made by the agency by competitive sealed proposals.
(2) The agency shall make a decision regarding the issuance of the certificate of need in accordance with the provisions of s. 287.057(16), rules adopted by the agency relating to intermediate care facilities for the developmentally disabled, and the criteria in s. 408.035, as further defined by rule.
(3) Notification of the decision shall be issued to all applicants not later than 28 calendar days after the date responses to a request for proposal are due.
(4) The procedures provided for under this section are exempt from the batching cycle requirements and the public hearing requirement of s. 408.039.
(5) The agency may use the competitive sealed proposal procedure for determining a certificate of need for other types of health care facilities and services if the agency identifies an unmet health care need and when funding in whole or in part for such health care facilities or services is authorized by the Legislature.
History.—s. 3, ch. 83-244; s. 42, ch. 85-81; s. 32, ch. 87-92; s. 3, ch. 89-308; s. 30, ch. 90-268; ss. 15, 18, ch. 92-33; s. 16, ch. 95-144; s. 13, ch. 2000-256; s. 14, ch. 2000-318; s. 67, ch. 2002-1; s. 37, ch. 2002-207; s. 33, ch. 2010-151.
Note.—Former s. 381.4961; s. 381.715.
408.0455 Rules; pending proceedings.—The rules of the agency in effect on June 30, 2004, shall remain in effect and shall be enforceable by the agency with respect to ss. 408.031-408.045 until such rules are repealed or amended by the agency.
History.—s. 38, ch. 87-92; s. 19, ch. 92-33; s. 74, ch. 92-289; s. 19, ch. 97-79; s. 4, ch. 97-98; s. 9, ch. 97-270; s. 12, ch. 2004-383.
Note.—Former s. 381.7155.
408.05 Florida Center for Health Information and Policy Analysis.—
(1) ESTABLISHMENT.—The agency shall establish a Florida Center for Health Information and Policy Analysis. The center shall establish a comprehensive health information system to provide for the collection, compilation, coordination, analysis, indexing, dissemination, and utilization of both purposefully collected and extant health-related data and statistics. The center shall be staffed with public health experts, biostatisticians, information system analysts, health policy experts, economists, and other staff necessary to carry out its functions.
(2) HEALTH-RELATED DATA.—The comprehensive health information system operated by the Florida Center for Health Information and Policy Analysis shall identify the best available data sources and coordinate the compilation of extant health-related data and statistics and purposefully collect data on:
(a) The extent and nature of illness and disability of the state population, including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality.
(b) The impact of illness and disability of the state population on the state economy and on other aspects of the well-being of the people in this state.
(c) Environmental, social, and other health hazards.
(d) Health knowledge and practices of the people in this state and determinants of health and nutritional practices and status.
(e) Health resources, including physicians, dentists, nurses, and other health professionals, by specialty and type of practice and acute, long-term care and other institutional care facility supplies and specific services provided by hospitals, nursing homes, home health agencies, and other health care facilities.
(f) Utilization of health care by type of provider.
(g) Health care costs and financing, including trends in health care prices and costs, the sources of payment for health care services, and federal, state, and local expenditures for health care.
(h) Family formation, growth, and dissolution.
(i) The extent of public and private health insurance coverage in this state.
(j) The quality of care provided by various health care providers.
(3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to produce comparable and uniform health information and statistics for the development of policy recommendations, the agency shall perform the following functions:
(a) Coordinate the activities of state agencies involved in the design and implementation of the comprehensive health information system.
(b) Undertake research, development, and evaluation respecting the comprehensive health information system.
(c) Review the statistical activities of state agencies to ensure that they are consistent with the comprehensive health information system.
(d) Develop written agreements with local, state, and federal agencies for the sharing of health-care-related data or using the facilities and services of such agencies. State agencies, local health councils, and other agencies under state contract shall assist the center in obtaining, compiling, and transferring health-care-related data maintained by state and local agencies. Written agreements must specify the types, methods, and periodicity of data exchanges and specify the types of data that will be transferred to the center.
(e) Establish by rule the types of data collected, compiled, processed, used, or shared. Decisions regarding center data sets should be made based on consultation with the State Consumer Health Information and Policy Advisory Council and other public and private users regarding the types of data which should be collected and their uses. The center shall establish standardized means for collecting health information and statistics under laws and rules administered by the agency.
(f) Establish minimum health-care-related data sets which are necessary on a continuing basis to fulfill the collection requirements of the center and which shall be used by state agencies in collecting and compiling health-care-related data. The agency shall periodically review ongoing health care data collections of the Department of Health and other state agencies to determine if the collections are being conducted in accordance with the established minimum sets of data.
(g) Establish advisory standards to ensure the quality of health statistical and epidemiological data collection, processing, and analysis by local, state, and private organizations.
(h) Prescribe standards for the publication of health-care-related data reported pursuant to this section which ensure the reporting of accurate, valid, reliable, complete, and comparable data. Such standards should include advisory warnings to users of the data regarding the status and quality of any data reported by or available from the center.
(i) Prescribe standards for the maintenance and preservation of the center’s data. This should include methods for archiving data, retrieval of archived data, and data editing and verification.
(j) Ensure that strict quality control measures are maintained for the dissemination of data through publications, studies, or user requests.
(k) Develop, in conjunction with the State Consumer Health Information and Policy Advisory Council, and implement a long-range plan for making available health care quality measures and financial data that will allow consumers to compare health care services. The health care quality measures and financial data the agency must make available shall include, but is not limited to, pharmaceuticals, physicians, health care facilities, and health plans and managed care entities. The agency shall update the plan and report on the status of its implementation annually. The agency shall also make the plan and status report available to the public on its Internet website. As part of the plan, the agency shall identify the process and timeframes for implementation, any barriers to implementation, and recommendations of changes in the law that may be enacted by the Legislature to eliminate the barriers. As preliminary elements of the plan, the agency shall:
1. Make available patient-safety indicators, inpatient quality indicators, and performance outcome and patient charge data collected from health care facilities pursuant to s. 408.061(1)(a) and (2). The terms “patient-safety indicators” and “inpatient quality indicators” shall be as defined by the Centers for Medicare and Medicaid Services, the National Quality Forum, the Joint Commission on Accreditation of Healthcare Organizations, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or a similar national entity that establishes standards to measure the performance of health care providers, or by other states. The agency shall determine which conditions, procedures, health care quality measures, and patient charge data to disclose based upon input from the council. When determining which conditions and procedures are to be disclosed, the council and the agency shall consider variation in costs, variation in outcomes, and magnitude of variations and other relevant information. When determining which health care quality measures to disclose, the agency:
a. Shall consider such factors as volume of cases; average patient charges; average length of stay; complication rates; mortality rates; and infection rates, among others, which shall be adjusted for case mix and severity, if applicable.
b. May consider such additional measures that are adopted by the Centers for Medicare and Medicaid Studies, National Quality Forum, the Joint Commission on Accreditation of Healthcare Organizations, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, or a similar national entity that establishes standards to measure the performance of health care providers, or by other states.
When determining which patient charge data to disclose, the agency shall include such measures as the average of undiscounted charges on frequently performed procedures and preventive diagnostic procedures, the range of procedure charges from highest to lowest, average net revenue per adjusted patient day, average cost per adjusted patient day, and average cost per admission, among others.
2. Make available performance measures, benefit design, and premium cost data from health plans licensed pursuant to chapter 627 or chapter 641. The agency shall determine which health care quality measures and member and subscriber cost data to disclose, based upon input from the council. When determining which data to disclose, the agency shall consider information that may be required by either individual or group purchasers to assess the value of the product, which may include membership satisfaction, quality of care, current enrollment or membership, coverage areas, accreditation status, premium costs, plan costs, premium increases, range of benefits, copayments and deductibles, accuracy and speed of claims payment, credentials of physicians, number of providers, names of network providers, and hospitals in the network. Health plans shall make available to the agency any such data or information that is not currently reported to the agency or the office.
3. Determine the method and format for public disclosure of data reported pursuant to this paragraph. The agency shall make its determination based upon input from the State Consumer Health Information and Policy Advisory Council. At a minimum, the data shall be made available on the agency’s Internet website in a manner that allows consumers to conduct an interactive search that allows them to view and compare the information for specific providers. The website must include such additional information as is determined necessary to ensure that the website enhances informed decisionmaking among consumers and health care purchasers, which shall include, at a minimum, appropriate guidance on how to use the data and an explanation of why the data may vary from provider to provider.
4. Publish on its website undiscounted charges for no fewer than 150 of the most commonly performed adult and pediatric procedures, including outpatient, inpatient, diagnostic, and preventative procedures.
(4) TECHNICAL ASSISTANCE.—
(a) The center shall provide technical assistance to persons or organizations engaged in health planning activities in the effective use of statistics collected and compiled by the center. The center shall also provide the following additional technical assistance services:
1. Establish procedures identifying the circumstances under which, the places at which, the persons from whom, and the methods by which a person may secure data from the center, including procedures governing requests, the ordering of requests, timeframes for handling requests, and other procedures necessary to facilitate the use of the center’s data. To the extent possible, the center should provide current data timely in response to requests from public or private agencies.
2. Provide assistance to data sources and users in the areas of database design, survey design, sampling procedures, statistical interpretation, and data access to promote improved health-care-related data sets.
3. Identify health care data gaps and provide technical assistance to other public or private organizations for meeting documented health care data needs.
4. Assist other organizations in developing statistical abstracts of their data sets that could be used by the center.
5. Provide statistical support to state agencies with regard to the use of databases maintained by the center.
6. To the extent possible, respond to multiple requests for information not currently collected by the center or available from other sources by initiating data collection.
7. Maintain detailed information on data maintained by other local, state, federal, and private agencies in order to advise those who use the center of potential sources of data which are requested but which are not available from the center.
8. Respond to requests for data which are not available in published form by initiating special computer runs on data sets available to the center.
9. Monitor innovations in health information technology, informatics, and the exchange of health information and maintain a repository of technical resources to support the development of a health information network.
(b) The agency shall administer, manage, and monitor grants to not-for-profit organizations, regional health information organizations, public health departments, or state agencies that submit proposals for planning, implementation, or training projects to advance the development of a health information network. Any grant contract shall be evaluated to ensure the effective outcome of the health information project.
(c) The agency shall initiate, oversee, manage, and evaluate the integration of health care data from each state agency that collects, stores, and reports on health care issues and make that data available to any health care practitioner through a state health information network.
(5) PUBLICATIONS; REPORTS; SPECIAL STUDIES.—The center shall provide for the widespread dissemination of data which it collects and analyzes. The center shall have the following publication, reporting, and special study functions:
(a) The center shall publish and make available periodically to agencies and individuals health statistics publications of general interest, including health plan consumer reports and health maintenance organization member satisfaction surveys; publications providing health statistics on topical health policy issues; publications that provide health status profiles of the people in this state; and other topical health statistics publications.
(b) The center shall publish, make available, and disseminate, promptly and as widely as practicable, the results of special health surveys, health care research, and health care evaluations conducted or supported under this section. Any publication by the center must include a statement of the limitations on the quality, accuracy, and completeness of the data.
(c) The center shall provide indexing, abstracting, translation, publication, and other services leading to a more effective and timely dissemination of health care statistics.
(d) The center shall be responsible for publishing and disseminating an annual report on the center’s activities.
(e) The center shall be responsible, to the extent resources are available, for conducting a variety of special studies and surveys to expand the health care information and statistics available for health policy analyses, particularly for the review of public policy issues. The center shall develop a process by which users of the center’s data are periodically surveyed regarding critical data needs and the results of the survey considered in determining which special surveys or studies will be conducted. The center shall select problems in health care for research, policy analyses, or special data collections on the basis of their local, regional, or state importance; the unique potential for definitive research on the problem; and opportunities for application of the study findings.
(6) PROVIDER DATA REPORTING.—This section does not confer on the agency the power to demand or require that a health care provider or professional furnish information, records of interviews, written reports, statements, notes, memoranda, or data other than as expressly required by law.
(7) BUDGET; FEES.—
(a) The Legislature intends that funding for the Florida Center for Health Information and Policy Analysis be appropriated from the General Revenue Fund.
(b) The Florida Center for Health Information and Policy Analysis may apply for and receive and accept grants, gifts, and other payments, including property and services, from any governmental or other public or private entity or person and make arrangements as to the use of same, including the undertaking of special studies and other projects relating to health-care-related topics. Funds obtained pursuant to this paragraph may not be used to offset annual appropriations from the General Revenue Fund.
(c) The center may charge such reasonable fees for services as the agency prescribes by rule. The established fees may not exceed the reasonable cost for such services. Fees collected may not be used to offset annual appropriations from the General Revenue Fund.
(8) STATE CONSUMER HEALTH INFORMATION AND POLICY ADVISORY COUNCIL.—
(a) There is established in the agency the State Consumer Health Information and Policy Advisory Council to assist the center in reviewing the comprehensive health information system, including the identification, collection, standardization, sharing, and coordination of health-related data, fraud and abuse data, and professional and facility licensing data among federal, state, local, and private entities and to recommend improvements for purposes of public health, policy analysis, and transparency of consumer health care information. The council shall consist of the following members:
1. An employee of the Executive Office of the Governor, to be appointed by the Governor.
2. An employee of the Office of Insurance Regulation, to be appointed by the director of the office.
3. An employee of the Department of Education, to be appointed by the Commissioner of Education.
4. Ten persons, to be appointed by the Secretary of Health Care Administration, representing other state and local agencies, state universities, business and health coalitions, local health councils, professional health-care-related associations, consumers, and purchasers.
(b) Each member of the council shall be appointed to serve for a term of 2 years following the date of appointment, except the term of appointment shall end 3 years following the date of appointment for members appointed in 2003, 2004, and 2005. A vacancy shall be filled by appointment for the remainder of the term, and each appointing authority retains the right to reappoint members whose terms of appointment have expired.
(c) The council may meet at the call of its chair, at the request of the agency, or at the request of a majority of its membership, but the council must meet at least quarterly.
(d) Members shall elect a chair and vice chair annually.
(e) A majority of the members constitutes a quorum, and the affirmative vote of a majority of a quorum is necessary to take action.
(f) The council shall maintain minutes of each meeting and shall make such minutes available to any person.
(g) Members of the council shall serve without compensation but shall be entitled to receive reimbursement for per diem and travel expenses as provided in s. 112.061.
(h) The council’s duties and responsibilities include, but are not limited to, the following:
1. To develop a mission statement, goals, and a plan of action for the identification, collection, standardization, sharing, and coordination of health-related data across federal, state, and local government and private sector entities.
2. To develop a review process to ensure cooperative planning among agencies that collect or maintain health-related data.
3. To create ad hoc issue-oriented technical workgroups on an as-needed basis to make recommendations to the council.
(9) APPLICATION TO OTHER AGENCIES.—Nothing in this section shall limit, restrict, affect, or control the collection, analysis, release, or publication of data by any state agency pursuant to its statutory authority, duties, or responsibilities.
History.—s. 39, ch. 88-394; s. 1, ch. 90-347; s. 50, ch. 91-297; s. 5, ch. 91-429; s. 14, ch. 92-33; s. 4, ch. 95-201; s. 37, ch. 97-103; s. 10, ch. 98-89; s. 176, ch. 99-8; s. 1, ch. 99-393; s. 42, ch. 2000-153; s. 16, ch. 2000-305; s. 435, ch. 2003-261; s. 11, ch. 2004-297; s. 12, ch. 2004-390; s. 1, ch. 2005-231; s. 3, ch. 2006-261; s. 24, ch. 2007-105; s. 5, ch. 2008-47; s. 89, ch. 2010-5.
Note.—Former s. 381.0612; s. 381.0401.
408.051 Florida Electronic Health Records Exchange Act.—
(1) SHORT TITLE.—This section may be cited as the “Florida Electronic Health Records Exchange Act.”
(2) DEFINITIONS.—As used in this section, the term:
(a) “Electronic health record” means a record of a person’s medical treatment which is created by a licensed health care provider and stored in an interoperable and accessible digital format.
(b) “Qualified electronic health record” means an electronic record of health-related information concerning an individual which includes patient demographic and clinical health information, such as medical history and problem lists, and which has the capacity to provide clinical decision support, to support physician order entry, to capture and query information relevant to health care quality, and to exchange electronic health information with, and integrate such information from, other sources.
(c) “Certified electronic health record technology” means a qualified electronic health record that is certified pursuant to s. 3001(c)(5) of the Public Health Service Act as meeting standards adopted under s. 3004 of such act which are applicable to the type of record involved, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals.
(d) “Health record” means any information, recorded in any form or medium, which relates to the past, present, or future health of an individual for the primary purpose of providing health care and health-related services.
(e) “Identifiable health record” means any health record that identifies the patient or with respect to which there is a reasonable basis to believe the information can be used to identify the patient.
(f) “Patient” means an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.
(g) “Patient representative” means a parent of a minor patient, a court-appointed guardian for the patient, a health care surrogate, or a person holding a power of attorney or notarized consent appropriately executed by the patient granting permission to a health care facility or health care provider to disclose the patient’s health care information to that person. In the case of a deceased patient, the term also means the personal representative of the estate of the deceased patient; the deceased patient’s surviving spouse, surviving parent, or surviving adult child; the parent or guardian of a surviving minor child of the deceased patient; the attorney for the patient’s surviving spouse, parent, or adult child; or the attorney for the parent or guardian of a surviving minor child.
(3) EMERGENCY RELEASE OF IDENTIFIABLE HEALTH RECORD.—A health care provider may release or access an identifiable health record of a patient without the patient’s consent for use in the treatment of the patient for an emergency medical condition, as defined in s. 395.002(8), when the health care provider is unable to obtain the patient’s consent or the consent of the patient representative due to the patient’s condition or the nature of the situation requiring immediate medical attention. A health care provider who in good faith releases or accesses an identifiable health record of a patient in any form or medium under this subsection is immune from civil liability for accessing or releasing an identifiable health record.
(4) UNIVERSAL PATIENT AUTHORIZATION FORM.—
(a) By July 1, 2010, the agency shall develop forms in both paper and electronic formats which may be used by a health care provider to document patient authorization for the use or release, in any form or medium, of an identifiable health record.
(b) The agency shall adopt by rule the authorization form and accompanying instructions and make the authorization form available on the agency’s website, pursuant to s. 408.05.
(c) A health care provider receiving an authorization form containing a request for the release of an identifiable health record shall accept the form as a valid authorization to release an identifiable health record. A health care provider may elect to accept the authorization form in either electronic or paper format or both. The individual or entity that submits the authorization form containing a request for the release of an identifiable health record shall determine which format is accepted by the health care provider prior to submitting the form.
(d) An individual or entity that submits a request for an identifiable health record is not required under this section to use the authorization form adopted and distributed by the agency.
(e) The exchange by a health care provider of an identifiable health record upon receipt of an authorization form completed and submitted in accordance with agency instructions creates a rebuttable presumption that the release of the identifiable health record was appropriate. A health care provider that releases an identifiable health record in reliance on the information provided to the health care provider on a properly completed authorization form does not violate any right of confidentiality and is immune from civil liability for accessing or releasing an identifiable health record under this subsection.
(f) A health care provider that exchanges an identifiable health record upon receipt of an authorization form shall not be deemed to have violated or waived any privilege protected under the statutory or common law of this state.
(5) PENALTIES.—A person who does any of the following may be liable to the patient or a health care provider that has released an identifiable health record in reliance on an authorization form presented to the health care provider by the person for compensatory damages caused by an unauthorized release, plus reasonable attorney’s fees and costs:
(a) Forges a signature on an authorization form or materially alters the authorization form of another person without the person’s authorization; or
(b) Obtains an authorization form or an identifiable health record of another person under false pretenses.
History.—s. 2, ch. 2009-172.
408.0512 Electronic health records system adoption loan program.—
(1) Subject to the availability of eligible donations from public or private entities and funding made available through s. 3014 of the Public Health Service Act, the agency may operate a certified electronic health record technology loan fund subject to a specific appropriation as authorized by the General Appropriations Act or as provided through the provisions of s. 216.181(11)(a) and (b).
(2) The agency shall adopt rules related to standard terms and conditions for use in the loan program.
History.—s. 3, ch. 2009-172.
408.061 Data collection; uniform systems of financial reporting; information relating to physician charges; confidential information; immunity.—
(1) The agency shall require the submission by health care facilities, health care providers, and health insurers of data necessary to carry out the agency’s duties. Specifications for data to be collected under this section shall be developed by the agency with the assistance of technical advisory panels including representatives of affected entities, consumers, purchasers, and such other interested parties as may be determined by the agency.
(a) Data submitted by health care facilities, including the facilities as defined in chapter 395, shall include, but are not limited to: case-mix data, patient admission and discharge data, hospital emergency department data which shall include the number of patients treated in the emergency department of a licensed hospital reported by patient acuity level, data on hospital-acquired infections as specified by rule, data on complications as specified by rule, data on readmissions as specified by rule, with patient and provider-specific identifiers included, actual charge data by diagnostic groups, financial data, accounting data, operating expenses, expenses incurred for rendering services to patients who cannot or do not pay, interest charges, depreciation expenses based on the expected useful life of the property and equipment involved, and demographic data. The agency shall adopt nationally recognized risk adjustment methodologies or software consistent with the standards of the Agency for Healthcare Research and Quality and as selected by the agency for all data submitted as required by this section. Data may be obtained from documents such as, but not limited to: leases, contracts, debt instruments, itemized patient bills, medical record abstracts, and related diagnostic information. Reported data elements shall be reported electronically in accordance with rule 59E-7.012, Florida Administrative Code. Data submitted shall be certified by the chief executive officer or an appropriate and duly authorized representative or employee of the licensed facility that the information submitted is true and accurate.
(b) Data to be submitted by health care providers may include, but are not limited to: professional organization and specialty board affiliations, Medicare and Medicaid participation, types of services offered to patients, amount of revenue and expenses of the health care provider, and such other data which are reasonably necessary to study utilization patterns. Data submitted shall be certified by the appropriate duly authorized representative or employee of the health care provider that the information submitted is true and accurate.
(c) Data to be submitted by health insurers may include, but are not limited to: claims, premium, administration, and financial information. Data submitted shall be certified by the chief financial officer, an appropriate and duly authorized representative, or an employee of the insurer that the information submitted is true and accurate.
(d) Data required to be submitted by health care facilities, health care providers, or health insurers shall not include specific provider contract reimbursement information. However, such specific provider reimbursement data shall be reasonably available for onsite inspection by the agency as is necessary to carry out the agency’s regulatory duties. Any such data obtained by the agency as a result of onsite inspections may not be used by the state for purposes of direct provider contracting and are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(e) A requirement to submit data shall be adopted by rule if the submission of data is being required of all members of any type of health care facility, health care provider, or health insurer. Rules are not required, however, for the submission of data for a special study mandated by the Legislature or when information is being requested for a single health care facility, health care provider, or health insurer.
(2) The agency shall, by rule, after consulting with appropriate professional and governmental advisory bodies and holding public hearings and considering existing and proposed systems of accounting and reporting utilized by health care facilities, specify a uniform system of financial reporting for each type of facility based on a uniform chart of accounts developed after considering any chart of accounts developed by the national association for such facilities and generally accepted accounting principles. Such systems shall, to the extent feasible, use existing accounting systems and shall minimize the paperwork required of facilities. This provision shall not be construed to authorize the agency to require health care facilities to adopt a uniform accounting system. As a part of such uniform system of financial reporting, the agency may require the filing of any information relating to the cost to the provider and the charge to the consumer of any service provided in such facility, except the cost of a physician’s services which is billed independently of the facility.
(3) When more than one licensed facility is operated by the reporting organization, the information required by this section shall be reported for each facility separately.
(4) Within 120 days after the end of its fiscal year, each health care facility, excluding continuing care facilities and nursing homes as defined in s. 408.07(14) and (37), shall file with the agency, on forms adopted by the agency and based on the uniform system of financial reporting, its actual financial experience for that fiscal year, including expenditures, revenues, and statistical measures. Such data may be based on internal financial reports which are certified to be complete and accurate by the provider. However, hospitals’ actual financial experience shall be their audited actual experience. Every nursing home shall submit to the agency, in a format designated by the agency, a statistical profile of the nursing home residents. The agency, in conjunction with the Department of Elderly Affairs and the Department of Health, shall review these statistical profiles and develop recommendations for the types of residents who might more appropriately be placed in their homes or other noninstitutional settings.
(5) In addition to information submitted in accordance with subsection (4), each nursing home shall track and file with the agency, on a form adopted by the agency, data related to each resident’s admission, discharge, or conversion to Medicaid; health and functional status; plan of care; and other information pertinent to the resident’s placement in a nursing home.
(6) The agency may require other reports based on the uniform system of financial reporting necessary to accomplish the purposes of this chapter.
(7) Portions of patient records obtained or generated by the agency containing the name, residence or business address, telephone number, social security or other identifying number, or photograph of any person or the spouse, relative, or guardian of such person, or any other identifying information which is patient-specific or otherwise identifies the patient, either directly or indirectly, are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(8) The identity of any health care provider, health care facility, or health insurer who submits any data which is proprietary business information to the agency pursuant to the provisions of this section shall remain confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. As used in this section, “proprietary business information” shall include, but not be limited to, information relating to specific provider contract reimbursement information; information relating to security measures, systems, or procedures; and information concerning bids or other contractual data, the disclosure of which would impair efforts to contract for goods or services on favorable terms or would injure the affected entity’s ability to compete in the marketplace. Notwithstanding the provisions of this subsection, any information obtained or generated pursuant to the provisions of former s. 407.61, either by the former Health Care Cost Containment Board or by the Agency for Health Care Administration upon transfer to that agency of the duties and functions of the former Health Care Cost Containment Board, is not confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. Such proprietary business information may be used in published analyses and reports or otherwise made available for public disclosure in such manner as to preserve the confidentiality of the identity of the provider. This exemption shall not limit the use of any information used in conjunction with investigation or enforcement purposes under the provisions of s. 456.073.
(9) No health care facility, health care provider, health insurer, or other reporting entity or its employees or agents shall be held liable for civil damages or subject to criminal penalties either for the reporting of patient data to the agency or for the release of such data by the agency as authorized by this chapter.
(10) The agency shall be the primary source for collection and dissemination of health care data. No other agency of state government may gather data from a health care provider licensed or regulated under this chapter without first determining if the data is currently being collected by the agency and affirmatively demonstrating that it would be more cost-effective for an agency of state government other than the agency to gather the health care data. The secretary shall ensure that health care data collected by the divisions within the agency is coordinated. It is the express intent of the Legislature that all health care data be collected by a single source within the agency and that other divisions within the agency, and all other agencies of state government, obtain data for analysis, regulation, and public dissemination purposes from that single source. Confidential information may be released to other governmental entities or to parties contracting with the agency to perform agency duties or functions as needed in connection with the performance of the duties of the receiving entity. The receiving entity or party shall retain the confidentiality of such information as provided for herein.
(11) The agency shall cooperate with local health councils and the state health planning agency with regard to health care data collection and dissemination and shall cooperate with state agencies in any efforts to establish an integrated health care database.
(12) It is the policy of this state that philanthropic support for health care should be encouraged and expanded, especially in support of experimental and innovative efforts to improve the health care delivery system.
(13) For purposes of determining reasonable costs of services furnished by health care facilities, unrestricted grants, gifts, and income from endowments shall not be deducted from any operating costs of such health care facilities, and, in addition, the following items shall not be deducted from any operating costs of such health care facilities:
(a) An unrestricted grant or gift, or income from such a grant or gift, which is not available for use as operating funds because of its designation by the health care facility’s governing board.
(b) A grant or similar payment which is made by a governmental entity and which is not available, under the terms of the grant or payment, for use as operating funds.
(c) The sale or mortgage of any real estate or other capital assets of the health care facility which the health care facility acquired through a gift or grant and which is not available for use as operating funds under the terms of the gift or grant or because of its designation by the health care facility’s governing board, except for recovery of the appropriate share of gains and losses realized from the disposal of depreciable assets.
History.—s. 68, ch. 92-33; s. 14, ch. 93-129; ss. 3, 4, ch. 95-201; s. 248, ch. 96-406; s. 40, ch. 97-98; s. 11, ch. 98-89; s. 27, ch. 98-166; s. 177, ch. 99-8; s. 43, ch. 2000-153; s. 19, ch. 2000-160; s. 11, ch. 2000-209; s. 30, ch. 2003-57; s. 9, ch. 2004-297; s. 4, ch. 2005-81; s. 4, ch. 2006-261.
408.0611 Electronic prescribing clearinghouse.—
(1) It is the intent of the Legislature to promote the implementation of electronic prescribing by health care practitioners, health care facilities, and pharmacies in order to prevent prescription drug abuse, improve patient safety, and reduce unnecessary prescriptions. To that end, it is the intent of the Legislature to create a clearinghouse of information on electronic prescribing to convey the process and advantages of electronic prescribing; to provide information regarding the availability of electronic prescribing products, including no-cost or low-cost products; and to regularly convene stakeholders to assess and accelerate the implementation of electronic prescribing.
(2) As used in this section, the term:
(a) “Electronic prescribing” means, at a minimum, the electronic review of the patient’s medication history, the electronic generation of the patient’s prescription, and the electronic transmission of the patient’s prescription to a pharmacy.
(b) “Health care practitioner” means an individual authorized by law to prescribe drugs.
(3) The agency shall work in collaboration with private sector electronic prescribing initiatives and relevant stakeholders to create a clearinghouse of information on electronic prescribing for health care practitioners, health care facilities, and pharmacies. These stakeholders shall include organizations that represent health care practitioners, organizations that represent health care facilities, organizations that represent pharmacies, organizations that operate electronic prescribing networks, organizations that create electronic prescribing products, and regional health information organizations. Specifically, the agency shall, by October 1, 2007:
(a) Provide on its website:
1. Information regarding the process of electronic prescribing and the availability of electronic prescribing products, including no-cost or low-cost products;
2. Information regarding the advantages of electronic prescribing, including using medication history data to prevent drug interactions, prevent allergic reactions, and deter doctor and pharmacy shopping for controlled substances;
3. Links to federal and private sector websites that provide guidance on selecting an appropriate electronic prescribing product; and
4. Links to state, federal, and private sector incentive programs for the implementation of electronic prescribing.
(b) Convene quarterly meetings of the stakeholders to assess and accelerate the implementation of electronic prescribing.
(4) Pursuant to s. 408.061, the agency shall monitor the implementation of electronic prescribing by health care practitioners, health care facilities, and pharmacies. By January 31 of each year, the agency shall report on the progress of implementation of electronic prescribing to the Governor and the Legislature. Information reported pursuant to this subsection shall include federal and private sector electronic prescribing initiatives and, to the extent that data is readily available from organizations that operate electronic prescribing networks, the number of health care practitioners using electronic prescribing and the number of prescriptions electronically transmitted.
History.—s. 3, ch. 2007-156.
408.062 Research, analyses, studies, and reports.—
(1) The agency shall conduct research, analyses, and studies relating to health care costs and access to and quality of health care services as access and quality are affected by changes in health care costs. Such research, analyses, and studies shall include, but not be limited to:
(a) The financial status of any health care facility or facilities subject to the provisions of this chapter.
(b) The impact of uncompensated charity care on health care facilities and health care providers.
(c) The state’s role in assisting to fund indigent care.
(d) In conjunction with the Office of Insurance Regulation, the availability and affordability of health insurance for small businesses.
(e) Total health care expenditures in the state according to the sources of payment and the type of expenditure.
(f) The quality of health services, using techniques such as small area analysis, severity adjustments, and risk-adjusted mortality rates.
(g) The development of physician information systems which are capable of providing data for health care consumers taking into account the amount of resources consumed, including such information at licensed facilities as defined in chapter 395, and the outcomes produced in the delivery of care.
(h) The collection of a statistically valid sample of data on the retail prices charged by pharmacies for the 100 most frequently prescribed medicines from any pharmacy licensed by this state as a special study authorized by the Legislature to be performed by the agency quarterly. If the drug is available generically, price data shall be reported for the generic drug and price data of a brand-named drug for which the generic drug is the equivalent shall be reported. The agency shall make available on its Internet website for each pharmacy, no later than October 1, 2006, drug prices for a 30-day supply at a standard dose. The data collected shall be reported for each drug by pharmacy and by metropolitan statistical area or region and updated quarterly.
(i) The use of emergency department services by patient acuity level and the implication of increasing hospital cost by providing nonurgent care in emergency departments. The agency shall submit an annual report based on this monitoring and assessment to the Governor, the Speaker of the House of Representatives, the President of the Senate, and the substantive legislative committees with the first report due January 1, 2006.
(j) The making available on its Internet website beginning no later than October 1, 2004, and in a hard-copy format upon request, of patient charge, volumes, length of stay, and performance indicators collected from health care facilities pursuant to s. 408.061(1)(a) for specific medical conditions, surgeries, and procedures provided in inpatient and outpatient facilities as determined by the agency. In making the determination of specific medical conditions, surgeries, and procedures to include, the agency shall consider such factors as volume, severity of the illness, urgency of admission, individual and societal costs, and whether the condition is acute or chronic. Performance outcome indicators shall be risk adjusted or severity adjusted, as applicable, using nationally recognized risk adjustment methodologies or software consistent with the standards of the Agency for Healthcare Research and Quality and as selected by the agency. The website shall also provide an interactive search that allows consumers to view and compare the information for specific facilities, a map that allows consumers to select a county or region, definitions of all of the data, descriptions of each procedure, and an explanation about why the data may differ from facility to facility. Such public data shall be updated quarterly. The agency shall submit an annual status report on the collection of data and publication of health care quality measures to the Governor, the Speaker of the House of Representatives, the President of the Senate, and the substantive legislative committees with the first status report due January 1, 2005.
(2) The agency may assess annually the caesarean section rate in Florida hospitals using the analysis methodology that the agency determines most appropriate. The data from this assessment shall be published periodically on the agency’s Internet website.
(3) The agency may also prepare such summaries and compilations or other supplementary reports based on the information analyzed by the agency under this section, as will advance the purposes of this chapter.
(4)(a) The agency shall conduct data-based studies and evaluations and make recommendations to the Legislature and the Governor concerning exemptions, the effectiveness of limitations of referrals, restrictions on investment interests and compensation arrangements, and the effectiveness of public disclosure. Such analysis shall include, but need not be limited to, utilization of services, cost of care, quality of care, and access to care. The agency may require the submission of data necessary to carry out this duty, which may include, but need not be limited to, data concerning ownership, Medicare and Medicaid, charity care, types of services offered to patients, revenues and expenses, patient-encounter data, and other data reasonably necessary to study utilization patterns and the impact of health care provider ownership interests in health-care-related entities on the cost, quality, and accessibility of health care.
(b) The agency may collect such data from any health facility or licensed health care provider as a special study.
(5) The agency shall develop and implement a strategy for the adoption and use of electronic health records, including the development of an electronic health information network for the sharing of electronic health records among health care facilities, health care providers, and health insurers. The agency may develop rules to facilitate the functionality and protect the confidentiality of electronic health records. The agency shall report to the Governor, the Speaker of the House of Representatives, and the President of the Senate on legislative recommendations to protect the confidentiality of electronic health records.
History.—s. 69, ch. 92-33; s. 12, ch. 93-129; s. 12, ch. 98-89; s. 17, ch. 2000-209; s. 31, ch. 2003-57; s. 10, ch. 2004-297; s. 5, ch. 2006-261.
408.063 Dissemination of health care information.—
(1) The agency, relying on data collected pursuant to this chapter, shall establish a reliable, timely, and consistent information system that distributes information and serves as the basis for the agency’s public education programs. The agency shall seek advice from consumers, health care purchasers, health care providers, health care facilities, health insurers, and local health councils in the development and implementation of its information system. Whenever appropriate, the agency shall use the local health councils for the dissemination of information and education of the public.
(2) The agency shall publish and disseminate information to the public which will enhance informed decisionmaking in the selection of health care providers, facilities, and services. Such publications may identify average charges for specified services, lengths of stay associated with established diagnostic groups, readmission rates, mortality rates, recommended guidelines for selection and use of health care providers, health care facilities, and health care services, and such other information as the agency deems appropriate.
(3) The agency shall educate consumers and health care purchasers by conducting or sponsoring seminars and other educational programs at locations throughout the state.
(4) The agency shall serve as a clearinghouse for information concerning:
(a) Innovations in the delivery of health care services and the enhancement of competition in the health care market.
(b) Federal and state legislative initiatives affecting the private health care delivery system and governmental health care programs.
(c) Health promotion, illness prevention, and wellness in the work setting.
(5) The agency shall publish annually a comprehensive report of state health expenditures. The report shall identify:
(a) The contribution of health care dollars made by all payors.
(b) The dollars expended by type of health care service in Florida.
(6) The staff of the agency may conduct or sponsor consumer information and education seminars at locations throughout the state and may hold public hearings to solicit consumer concerns or complaints relating to health care costs and make recommendations to the agency for study, action, or investigation.
History.—s. 70, ch. 92-33; s. 13, ch. 98-89.
408.07 Definitions.—As used in this chapter, with the exception of ss. 408.031-408.045, the term:
(1) “Accepted” means that the agency has found that a report or data submitted by a health care facility or a health care provider contains all schedules and data required by the agency and has been prepared in the format specified by the agency, and otherwise conforms to applicable rule or Florida Hospital Uniform Reporting System manual requirements regarding reports in effect at the time such report was submitted, and the data are mathematically reasonable and accurate.
(2) “Adjusted admission” means the sum of acute and intensive care admissions divided by the ratio of inpatient revenues generated from acute, intensive, ambulatory, and ancillary patient services to gross revenues. If a hospital reports only subacute admissions, then “adjusted admission” means the sum of subacute admissions divided by the ratio of total inpatient revenues to gross revenues.
(3) “Agency” means the Agency for Health Care Administration.
(4) “Alcohol or chemical dependency treatment center” means an organization licensed under chapter 397.
(5) “Ambulatory care center” means an organization which employs or contracts with licensed health care professionals to provide diagnosis or treatment services predominantly on a walk-in basis and the organization holds itself out as providing care on a walk-in basis. Such an organization is not an ambulatory care center if it is wholly owned and operated by five or fewer health care providers.
(6) “Ambulatory surgical center” means a facility licensed as an ambulatory surgical center under chapter 395.
(7) “Audited actual data” means information contained within financial statements examined by an independent, Florida-licensed, certified public accountant in accordance with generally accepted auditing standards, but does not include data within a financial statement about which the certified public accountant does not express an opinion or issues a disclaimer.
(8) “Birth center” means an organization licensed under s. 383.305.
(9) “Cardiac catheterization laboratory” means a freestanding facility that employs or contracts with licensed health care professionals to provide diagnostic or therapeutic services for cardiac conditions such as cardiac catheterization or balloon angioplasty.
(10) “Case mix” means a calculated index for each health care facility or health care provider, based on patient data, reflecting the relative costliness of the mix of cases to that facility or provider compared to a state or national mix of cases.
(11) “Clinical laboratory” means a facility licensed under s. 483.091, excluding: any hospital laboratory defined under s. 483.041(6); any clinical laboratory operated by the state or a political subdivision of the state; any blood or tissue bank where the majority of revenues are received from the sale of blood or tissue and where blood, plasma, or tissue is procured from volunteer donors and donated, processed, stored, or distributed on a nonprofit basis; and any clinical laboratory which is wholly owned and operated by physicians who are licensed pursuant to chapter 458 or chapter 459 and who practice in the same group practice, and at which no clinical laboratory work is performed for patients referred by any health care provider who is not a member of that same group practice.
(12) “Comprehensive rehabilitative hospital” or “rehabilitative hospital” means a hospital licensed by the agency as a specialty hospital as defined in s. 395.002; provided that the hospital provides a program of comprehensive medical rehabilitative services and is designed, equipped, organized, and operated solely to deliver comprehensive medical rehabilitative services, and further provided that all licensed beds in the hospital are classified as “comprehensive rehabilitative beds” pursuant to s. 395.003(4), and are not classified as “general beds.”
(13) “Consumer” means any person other than a person who administers health activities, is a member of the governing body of a health care facility, provides health services, has a fiduciary interest in a health facility or other health agency or its affiliated entities, or has a material financial interest in the rendering of health services.
(14) “Continuing care facility” means a facility licensed under chapter 651.
(15) “Critical access hospital” means a hospital that meets the definition of “critical access hospital” in s. 1861(mm)(1) of the Social Security Act and that is certified by the Secretary of Health and Human Services as a critical access hospital.
(16) “Cross-subsidization” means that the revenues from one type of hospital service are sufficiently higher than the costs of providing such service as to offset some of the costs of providing another type of service in the hospital. Cross-subsidization results from the lack of a direct relationship between charges and the costs of providing a particular hospital service or type of service.
(17) “Deductions from gross revenue” or “deductions from revenue” means reductions from gross revenue resulting from inability to collect payment of charges. For hospitals, such reductions include contractual adjustments; uncompensated care; administrative, courtesy, and policy discounts and adjustments; and other such revenue deductions, but also includes the offset of restricted donations and grants for indigent care.
(18) “Diagnostic-imaging center” means a freestanding outpatient facility that provides specialized services for the diagnosis of a disease by examination and also provides radiological services. Such a facility is not a diagnostic-imaging center if it is wholly owned and operated by physicians who are licensed pursuant to chapter 458 or chapter 459 and who practice in the same group practice and no diagnostic-imaging work is performed at such facility for patients referred by any health care provider who is not a member of that same group practice.
(19) “FHURS” means the Florida Hospital Uniform Reporting System developed by the agency.
(20) “Freestanding” means that a health facility bills and receives revenue which is not directly subject to the hospital assessment for the Public Medical Assistance Trust Fund as described in s. 395.701.
(21) “Freestanding radiation therapy center” means a facility where treatment is provided through the use of radiation therapy machines that are registered under s. 404.22 and the provisions of the Florida Administrative Code implementing s. 404.22. Such a facility is not a freestanding radiation therapy center if it is wholly owned and operated by physicians licensed pursuant to chapter 458 or chapter 459 who practice within the specialty of diagnostic or therapeutic radiology.
(22) “GRAA” means gross revenue per adjusted admission.
(23) “Gross revenue” means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges, and other operating revenue. Gross revenues do not include contributions, donations, legacies, or bequests made to a hospital without restriction by the donors.
(24) “Health care facility” means an ambulatory surgical center, a hospice, a nursing home, a hospital, a diagnostic-imaging center, a freestanding or hospital-based therapy center, a clinical laboratory, a home health agency, a cardiac catheterization laboratory, a medical equipment supplier, an alcohol or chemical dependency treatment center, a physical rehabilitation center, a lithotripsy center, an ambulatory care center, a birth center, or a nursing home component licensed under chapter 400 within a continuing care facility licensed under chapter 651.
(25) “Health care provider” means a health care professional licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 463, chapter 464, chapter 465, chapter 466, part I, part III, part IV, part V, or part X of chapter 468, chapter 483, chapter 484, chapter 486, chapter 490, or chapter 491.
(26) “Health care purchaser” means an employer in the state, other than a health care facility, health insurer, or health care provider, who provides health care coverage for her or his employees.
(27) “Health insurer” means any insurance company authorized to transact health insurance in the state, any insurance company authorized to transact health insurance or casualty insurance in the state that is offering a minimum premium plan or stop-loss coverage for any person or entity providing health care benefits, any self-insurance plan as defined in s. 624.031, any health maintenance organization authorized to transact business in the state pursuant to part I of chapter 641, any prepaid health clinic authorized to transact business in the state pursuant to part II of chapter 641, any multiple-employer welfare arrangement authorized to transact business in the state pursuant to ss. 624.436-624.45, or any fraternal benefit society providing health benefits to its members as authorized pursuant to chapter 632.
(28) “Home health agency” means an organization licensed under part III of chapter 400.
(29) “Hospice” means an organization licensed under part IV of chapter 400.
(30) “Hospital” means a health care institution licensed by the Agency for Health Care Administration as a hospital under chapter 395.
(31) “Lithotripsy center” means a freestanding facility that employs or contracts with licensed health care professionals to provide diagnosis or treatment services using electro-hydraulic shock waves.
(32) “Local health council” means the agency defined in s. 408.033.
(33) “Market basket index” means the Florida hospital input price index (FHIPI), which is a statewide market basket index used to measure inflation in hospital input prices weighted for the Florida-specific experience which uses multistate regional and state-specific price measures, when available. The index shall be constructed in the same manner as the index employed by the Secretary of the United States Department of Health and Human Services for determining the inflation in hospital input prices for purposes of Medicare reimbursement.
(34) “Medical equipment supplier” means an organization that provides medical equipment and supplies used by health care providers and health care facilities in the diagnosis or treatment of disease.
(35) “Net revenue” means gross revenue minus deductions from revenue.
(36) “New hospital” means a hospital in its initial year of operation as a licensed hospital and does not include any facility which has been in existence as a licensed hospital, regardless of changes in ownership, for over 1 calendar year.
(37) “Nursing home” means a facility licensed under s. 400.062 or, for resident level and financial data collection purposes only, any institution licensed under chapter 395 and which has a Medicare or Medicaid certified distinct part used for skilled nursing home care, but does not include a facility licensed under chapter 651.
(38) “Operating expenses” means total expenses excluding income taxes.
(39) “Other operating revenue” means all revenue generated from hospital operations other than revenue directly associated with patient care.
(40) “Physical rehabilitation center” means an organization that employs or contracts with health care professionals licensed under part I or part III of chapter 468 or chapter 486 to provide speech, occupational, or physical therapy services on an outpatient or ambulatory basis.
(41) “Prospective payment arrangement” means a financial agreement negotiated between a hospital and an insurer, health maintenance organization, preferred provider organization, or other third-party payor which contains, at a minimum, the elements provided for in s. 408.50.
(42) “Rate of return” means the financial indicators used to determine or demonstrate reasonableness of the financial requirements of a hospital. Such indicators shall include, but not be limited to: return on assets, return on equity, total margin, and debt service coverage.
(43) “Rural hospital” means an acute care hospital licensed under chapter 395, having 100 or fewer licensed beds and an emergency room, and which is:
(a) The sole provider within a county with a population density of no greater than 100 persons per square mile;
(b) An acute care hospital, in a county with a population density of no greater than 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from another acute care hospital within the same county;
(c) A hospital supported by a tax district or subdistrict whose boundaries encompass a population of 100 persons or fewer per square mile;
(d) A hospital with a service area that has a population of 100 persons or fewer per square mile. As used in this paragraph, the term “service area” means the fewest number of zip codes that account for 75 percent of the hospital’s discharges for the most recent 5-year period, based on information available from the hospital inpatient discharge database in the Florida Center for Health Information and Policy Analysis at the Agency for Health Care Administration; or
(e) A critical access hospital.
Population densities used in this subsection must be based upon the most recently completed United States census. A hospital that received funds under s. 409.9116 for a quarter beginning no later than July 1, 2002, is deemed to have been and shall continue to be a rural hospital from that date through June 30, 2015, if the hospital continues to have 100 or fewer licensed beds and an emergency room, or meets the criteria of s. 395.602(2)(e)4. An acute care hospital that has not previously been designated as a rural hospital and that meets the criteria of this subsection shall be granted such designation upon application, including supporting documentation, to the Agency for Health Care Administration.
(44) “Special study” means a nonrecurring data-gathering and analysis effort designed to aid the agency in meeting its responsibilities pursuant to this chapter.
(45) “Teaching hospital” means any Florida hospital officially affiliated with an accredited Florida medical school which exhibits activity in the area of graduate medical education as reflected by at least seven different graduate medical education programs accredited by the Accreditation Council for Graduate Medical Education or the Council on Postdoctoral Training of the American Osteopathic Association and the presence of 100 or more full-time equivalent resident physicians. The Director of the Agency for Health Care Administration shall be responsible for determining which hospitals meet this definition.
History.—s. 71, ch. 92-33; s. 75, ch. 92-289; s. 13, ch. 93-129; s. 39, ch. 93-217; s. 17, ch. 95-144; s. 38, ch. 97-103; s. 2, ch. 98-14; s. 2, ch. 98-21; s. 14, ch. 98-89; s. 44, ch. 2000-153; s. 28, ch. 2000-163; s. 2, ch. 2000-227; s. 2, ch. 2003-258; s. 5, ch. 2005-81; s. 77, ch. 2006-197; s. 10, ch. 2006-261; s. 15, ch. 2009-223.
408.08 Inspections and audits; violations; penalties; fines; enforcement.—
(1) The agency may inspect and audit books and records of individual or corporate ownership, including books and records of related organizations with which a health care provider or a health care facility had transactions, for compliance with this chapter. Upon presentation of a written request for inspection to a health care provider or a health care facility by the agency or its staff, the health care provider or the health care facility shall make available to the agency or its staff for inspection, copying, and review all books and records relevant to the determination of whether the health care provider or the health care facility has complied with this chapter.
(2) Any health care facility that refuses to file a report, fails to timely file a report, files a false report, or files an incomplete report and upon notification fails to timely file a complete report required under s. 408.061; that violates this section, s. 408.061, or s. 408.20, or rule adopted thereunder; or that fails to provide documents or records requested by the agency under this chapter shall be punished by a fine not exceeding $1,000 per day for each day in violation, to be imposed and collected by the agency. Pursuant to rules adopted by the agency, the agency may, upon a showing of good cause, grant a one-time extension of any deadline for a health care facility to timely file a report as required by this section, s. 408.061, or s. 408.20.
(3) Any health care provider that refuses to file a report, fails to timely file a report, files a false report, or files an incomplete report and upon notification fails to timely file a complete report required under s. 408.061; that violates this section, s. 408.061, or s. 408.20, or rule adopted thereunder; or that fails to provide documents or records requested by the agency under this chapter shall be referred to the appropriate licensing board which shall take appropriate action against the health care provider.
(4) If a health insurer does not comply with the requirements of s. 408.061, the agency shall report a health insurer’s failure to comply to the Office of Insurance Regulation of the Financial Services Commission, which shall take into account the failure by the health insurer to comply in conjunction with its approval authority under s. 627.410. The agency shall adopt any rules necessary to carry out its responsibilities required by this subsection.
(5) Refusal to file, failure to timely file, or filing false or incomplete reports or other information required to be filed under the provisions of this chapter, failure to pay or failure to timely pay any assessment authorized to be collected by the agency, or violation of any other provision of this chapter or lawfully entered order of the agency or rule adopted under this chapter, shall be punished by a fine not exceeding $1,000 a day for each day in violation, to be fixed, imposed, and collected by the agency. Each day in violation shall be considered a separate offense.
(6) Notwithstanding any other provisions of this chapter, when a hospital alleges that a factual determination made by the agency is incorrect, the burden of proof shall be on the hospital to demonstrate that such determination is, in light of the total record, not supported by a preponderance of the evidence. The burden of proof remains with the hospital in all cases involving administrative agency action.
History.—s. 73, ch. 92-33; s. 77, ch. 92-289; s. 16, ch. 93-129; s. 23, ch. 95-146; s. 15, ch. 98-89; s. 1, ch. 98-120; s. 45, ch. 2000-153; s. 436, ch. 2003-261.
408.09 Assistance on cost containment strategies.—The agency shall:
(1) Assist purchasers and employers who seek technical assistance from the agency for the purpose of cost-effective purchasing of health care.
(2) Develop cost containment strategies for use by providers, employers, or consumers of health care.
(3) Develop an outreach program to assist small business to include cost containment initiatives for small business health insurance plans.
(4) Assist existing health coalitions and local health councils as needed in carrying out their respective goals in an efficient and effective manner.
History.—s. 75, ch. 92-33.
408.10 Consumer complaints.—The agency shall:
(1) Publish and make available to the public a toll-free telephone number for the purpose of handling consumer complaints and shall serve as a liaison between consumer entities and other private entities and governmental entities for the disposition of problems identified by consumers of health care.
(2) Be empowered to investigate consumer complaints relating to problems with health care facilities’ billing practices and issue reports to be made public in any cases where the agency determines the health care facility has engaged in billing practices which are unreasonable and unfair to the consumer.
History.—s. 76, ch. 92-33.
408.15 Powers of the agency.—In addition to the powers granted to the agency elsewhere in this chapter, the agency is authorized to:
(1) Enter into contracts and execute all instruments necessary or convenient for carrying out its business.
(2) Acquire, own, hold, dispose of, and encumber personal property and to lease real property in exercising its powers and performing its duties.
(3) Enter into agreements with any federal, state, or municipal agency, or other public institution, or with any private individual, partnership, firm, corporation, association, or other entity.
(4) Establish ad hoc advisory committees to expand public participation in agency decisions and draw on the experience of representatives from all areas of health insurance, financing, cost containment, and operations, including, but not limited to, providers, consumers, third-party payors, businesses, and academicians.
(5) Establish such staff as needed to carry out the purposes of this chapter.
(6) Apply for and receive and accept grants, gifts, and other payments, including property and services, from any governmental or other public and private entity or person and make arrangements as to the use of same. Funds obtained under this subsection may be used as matching funds for public or private grants.
(7) Seek federal statutory changes and any waivers of federal laws or regulations that will aid in implementing health care reforms. This may include seeking amendments to:
(a) The Employee Retirement and Income Security Act of 1974 to permit greater state regulation of employer insurance plans.
(b) The Medicaid program to permit alternative organizational alignments, elimination of all program eligibility requirements except income, and a moratorium on further federal mandates.
(c) The Medicare program to seek state administration of benefits, provider payments, or case management of beneficiaries.
(d) Federal tax laws to permit a 100-percent tax deduction for all private health insurance plans, including those of self-employed persons and unincorporated employers, and reform of the flexible sharing account requirements to maximize pretax health care expenditures.
(e) Other federal programs to permit full implementation of state health care reforms.
(8) Adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter.
(9) Hold public hearings, conduct investigations, and subpoena witnesses, papers, records, and documents in connection therewith. The agency may administer oaths or affirmations in any hearing or investigation.
(10) Exercise all other powers which are reasonably necessary or essential to carry out the expressed intent, objects, and purposes of this chapter, unless specifically prohibited in this chapter.
(11) Grant extensions of time for compliance with any filing requirement of this chapter.
(12) Establish, in coordination with the Department of Health, uniform standards of care to be provided in special needs units or shelters during times of emergency or major disaster.
History.—s. 77, ch. 92-33; s. 111, ch. 98-200; s. 19, ch. 2000-140; s. 12, ch. 2000-209.
408.16 Health Care Trust Fund; moneys to be deposited therein.—
(1) There is created in the State Treasury a special fund to be designated as the Health Care Trust Fund, which shall be used in the operation of the Agency for Health Care Administration in the performance of the various functions and duties required of it by law.
(2) All fees, license fees, and other charges collected by the agency shall be deposited in the State Treasury to the credit of the Health Care Trust Fund, to be used in the operation of the agency as authorized by the Legislature. However, penalties and interest assessed and collected by the agency shall not be deposited in the trust fund but shall be deposited in the General Revenue Fund. The Health Care Trust Fund shall be subject to the service charge imposed pursuant to chapter 215.
(3) The agency shall maintain separate revenue and expenditure accounts in the Health Care Trust Fund for every provider licensed by the agency.
(4) All other moneys in the Health Care Trust Fund shall be for the use of the agency in the performance of its functions and duties as provided by law, subject to the fiscal and budgetary provisions of general law and the General Appropriations Act.
History.—s. 50, ch. 92-33; s. 23, ch. 93-129; s. 36, ch. 96-418; s. 59, ch. 97-261.
Note.—Former s. 455.2205.
408.18 Health Care Community Antitrust Guidance Act; antitrust no-action letter; market-information collection and education.—
(1) This section may be cited as the “Florida Health Care Community Antitrust Guidance Act.”
(2) This section is created to provide instruction to the health care community in a time of tremendous change, and to resolve, as completely as possible, the problem of antitrust uncertainty that may deter mergers, joint ventures, or other business activities that can improve the delivery of health care, without creating costly, time-consuming regulations that can lead to more litigation and delay.
(3) For purposes of this section, the term:
(a) “Health care community” means all licensed health care providers, insurers, networks, purchasers, and other participants in the health care system.
(b) “Antitrust no-action letter” means a letter that states the intention of the Attorney General’s office not to take antitrust enforcement actions with respect to the requesting party, based on the specific facts then presented, as of the date the letter is issued.
(4)(a) Members of the health care community who seek antitrust guidance may request a review of their proposed business activity by the Attorney General’s office. In conducting its review, the Attorney General’s office may seek whatever documentation, data, or other material it deems necessary from the Agency for Health Care Administration, the Florida Center for Health Information and Policy Analysis, and the Office of Insurance Regulation of the Financial Services Commission.
(b) In order to receive an antitrust no-action letter, a member of the health care community must submit in writing to the Attorney General’s office a request for an antitrust no-action letter.
(c) The requesting parties are under an affirmative obligation to make full, true, and accurate disclosure with respect to the activities for which the antitrust no-action letter is requested. Requests relating to unnamed persons or companies may not be answered. Each request must be accompanied by all relevant material information; relevant data, including background information; complete copies of all operative documents; the provisions of law under which the request arises; and detailed statements of all collateral oral understandings, if any.
(d) All parties requesting the antitrust no-action letter must provide the Attorney General’s office with whatever additional information or documents the Attorney General’s office requests for its review of the matter.
(5) The Attorney General’s office shall act on the no-action letter request within 90 days after it receives all information necessary to complete its review.
(6) At the completion of its review of a request for an antitrust no-action letter, the Attorney General’s office shall do one of the following:
(a) Issue the antitrust no-action letter;
(b) Decline to issue any type of letter; or
(c) Take such other position or action as it considers appropriate.
(7) The recipient of a no-action letter must annually file with the Attorney General’s office an affidavit stating that there has been no change in the facts the recipient has presented, at which time the Attorney General may renew the no-action letter. As long as there is no change in any material fact, the Attorney General’s office is estopped from bringing any action pursuant to the antitrust laws concerning any specific conduct that is the subject of the no-action letter. Further, the no-action letter, if it meets the requirements of the Florida Evidence Code, is admissible in any court proceeding in this state. The Attorney General’s office remains free to bring an action or proceeding based on a different set of facts presented.
(8) The Agency for Health Care Administration shall coordinate all existing data received, such as the hospital patient discharge database, ambulatory patient database, ambulatory facilities’ financial data, health facility licensure and certification tracking system, health facility plans and construction data, local health council data, Medicaid data, provider claims data, psychiatric hospital discharge data, pharmaceutical data, licensure data of health maintenance organizations, licensure data of health insurers, health care practitioner licensure data, hospital financial database, health facility utilization and projected need data, nursing home financial database, nursing home patient database, and joint venture database. This information shall be made available to the Attorney General’s office, as needed.
(9) When the member of the health care community seeking the no-action letter is regulated by the Office of Insurance Regulation, the office shall make available to the Attorney General’s office, as needed, any information it maintains in its regulatory capacity.
History.—s. 12, ch. 96-223; s. 98, ch. 97-261; s. 437, ch. 2003-261; s. 11, ch. 2006-261.
Note.—Former s. 455.277.
408.185 Information submitted for review of antitrust issues; confidentiality.—The following information held by the Office of the Attorney General, which is submitted by a member of the health care community pursuant to a request for an antitrust no-action letter shall be confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution for 1 year after the date of submission.
(1) Documents that reveal trade secrets as defined in s. 688.002.
(2) Preferred provider organization contracts.
(3) Health maintenance organization contracts.
(4) Documents that reveal a health care provider’s marketing plan.
(5) Proprietary confidential business information as defined in s. 364.183(3).
History.—s. 1, ch. 96-373; s. 99, ch. 97-261; s. 1, ch. 2001-72.
Note.—Former s. 455.2775.
408.20 Assessments; Health Care Trust Fund.—
(1) The data collection and analysis activities of the agency shall be financed, in part, by an assessment on:
(a) Hospitals in an amount to be determined annually by the agency, but not to exceed 0.04 percent of the gross operating expenses of each hospital for the provision of hospital services for its last fiscal year. Every new hospital shall pay its initial assessment upon being licensed by the state and shall base its assessment payment during the first year of operation upon its projections for gross operating expenses for that year. Each hospital under new ownership shall pay its initial assessment for the first year of operation under new ownership based on its gross operating expenses for the last fiscal year under previous ownership. The assessments shall be levied and collected quarterly.
(b) Nursing homes in an amount set by the agency to cover the agency’s approved budget. The agency shall calculate the amount to be collected per bed, rounded to the nearest whole dollar. All assessments collected under this section which are due after the date of notification by the agency shall be at a rate sufficient to cover the agency’s approved budget. Assessments shall be levied and collected annually by the agency. Each new nursing home shall pay its initial assessment upon being licensed, and each nursing home under new ownership shall pay its initial assessment under the new ownership based on its number of beds.
(2) All moneys collected are to be deposited into the Health Care Trust Fund created pursuant to s. 408.16.
(3) Any amounts raised by the collection of assessments provided for in this section which are not required to meet appropriations in the budget act for the current fiscal year shall be available to the agency in succeeding years.
(4) Hospitals operated by the Department of Children and Family Services, the Department of Health, or the Department of Corrections are exempt from the assessments required under this section.
History.—s. 78, ch. 92-33; s. 34, ch. 96-418; s. 174, ch. 98-166; s. 178, ch. 99-8.
408.301 Legislative findings.—The Legislature has found that access to quality, affordable, health care for all Floridians is an important goal for the state. The Legislature recognizes that there are Floridians with special health care and social needs which require particular attention. The people served by the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs are examples of citizens with special needs. The Legislature further recognizes that the Medicaid program is an intricate part of the service delivery system for the special needs citizens. However, the Agency for Health Care Administration is not a service provider and does not develop or direct programs for the special needs citizens. Therefore, it is the intent of the Legislature that the Agency for Health Care Administration work closely with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs in developing plans for assuring access to all Floridians in order to assure that the needs of special citizens are met.
History.—s. 18, ch. 93-129; s. 179, ch. 99-8; s. 13, ch. 2000-209; s. 83, ch. 2004-267.
408.302 Interagency agreement.—
(1) The Agency for Health Care Administration shall enter into an interagency agreement with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs to assure coordination and cooperation in serving special needs citizens. The agreement shall include the requirement that the secretaries or directors of the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs approve, prior to adoption, any rule developed by the Agency for Health Care Administration where such rule has a direct impact on the mission of the respective state agencies, their programs, or their budgets.
(2) For rules which indirectly impact on the mission of the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs, their programs, or their budgets, the concurrence of the respective secretaries or directors on the rule is required.
(3) For all other rules developed by the Agency for Health Care Administration, coordination with the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs is encouraged.
(4) The interagency agreement shall also include any other provisions necessary to ensure a continued cooperative working relationship between the Agency for Health Care Administration and the Department of Children and Family Services, the Agency for Persons with Disabilities, the Department of Health, and the Department of Elderly Affairs as each strives to meet the needs of the citizens of Florida.
History.—s. 19, ch. 93-129; s. 180, ch. 99-8; s. 84, ch. 2004-267.
408.40 Public Counsel.—
(1) Notwithstanding any other provisions of this chapter, the Public Counsel shall represent the public in any proceeding before the agency or its advisory panels in any administrative hearing conducted pursuant to chapter 120 or before any other state and federal agencies and courts in any issue before the agency, any court, or any agency. With respect to any such proceeding, the Public Counsel is subject to the provisions of and may use the powers granted to him or her by ss. 350.061-350.0614.
(2) The Public Counsel shall:
(a) Recommend to the agency, by petition, the commencement of any proceeding or action or to appear, in the name of the state or its citizens, in any proceeding or action before the agency and urge therein any position that he or she deems to be in the public interest, whether consistent or inconsistent with positions previously adopted by the agency, and use therein all forms of discovery available to attorneys in civil actions generally, subject to protective orders of the agency, which shall be reviewable by summary procedure in the circuit courts of this state.
(b) Have access to and use of all files, records, and data of the agency available to any other attorney representing parties in a proceeding before the agency.
(c) In any proceeding in which he or she has participated as a party, seek review of any determination, finding, or order of the agency, or of any administrative law judge, or any hearing officer or hearing examiner designated by the agency, in the name of the state or its citizens.
(d) Prepare and issue reports, recommendations, and proposed orders to the agency, the Governor, and the Legislature on any matter or subject within the jurisdiction of the agency, and to make such recommendations as he or she deems appropriate for legislation relative to agency procedures, rules, jurisdiction, personnel, and functions.
(e) Appear before other state agencies, federal agencies, and state and federal courts in connection with matters under the jurisdiction of the agency, in the name of the state or its citizens.
History.—s. 80, ch. 92-33; s. 192, ch. 96-410; s. 1017, ch. 97-103; s. 16, ch. 98-89.
408.50 Prospective payment arrangements.—
(1) Hospitals as defined in s. 395.002, and health insurers regulated pursuant to parts VI and VII of chapter 627, shall establish prospective payment arrangements that provide hospitals with financial incentives to contain costs. Each hospital shall enter into a rate agreement with each health insurer which represents 10 percent or more of the private-pay patients of the hospital to establish a prospective payment arrangement. Hospitals and health insurers regulated pursuant to this section shall report annually the results of each specific prospective payment arrangement adopted by each hospital and health insurer to the board. The agency shall report a health insurer’s failure to comply to the Office of Insurance Regulation of the Financial Services Commission, which shall take into account the failure by the health insurer to comply in conjunction with its approval authority under s. 627.410. The agency shall adopt any rules necessary to carry out its responsibilities required by this section.
(2) The prospective payment system established pursuant to this section shall include, at a minimum, the following elements:
(a) A maximum allowable payment amount established for individual hospital products, services, patient diagnoses, patient day, patient admission, or per insured, or any combination thereof, which is preset at the beginning of the budget year of the hospital and fixed for the entirety of that budget year, except when extenuating and unusual circumstances acceptable to the department warrant renegotiation.
(b) Timely payment to the hospital by the insurer or the insured, or both, of the maximum allowable payment amount, as so negotiated by the insurer or group of insurers.
(c) Acceptance by the hospital of the maximum payment amount as payment in full, which shall include any deductible or coinsurance provided for in the insurer’s benefit plan.
(d) Utilization reviews for appropriateness of treatment.
(e) Preadmission screening of nonemergency admissions.
(3) Nothing contained in this section prohibits the inclusion of deductibles, coinsurance, or other cost containment provisions in any health insurance policy.
History.—s. 81, ch. 92-33; s. 438, ch. 2003-261.
408.70 Health care; managed competition; legislative findings and intent.—
(1) The Legislature finds that the current health care system in this state does not provide access to affordable health care for all persons in this state. Almost one in five persons is without health insurance. For many, entry into the health care system is through a hospital emergency room rather than a primary care setting. The availability of preventive and primary care and managed, family-based care is limited. Health insurance underwriting practices have led to the avoidance, rather than to the sharing, of insurance risks, limiting access to coverages for small-sized employer groups and high-risk populations. Spiraling premium costs have placed health insurance policies out of the reach of many small-sized and medium-sized businesses and their employees. Lack of outcome and cost information has forced individuals and businesses to make critical health care decisions with little guidance or leverage. Health care resources have not been allocated efficiently, leading to excess and unevenly distributed capacity. These factors have contributed to the high cost of health care. Rural and other medically underserved areas have too few health care resources. Comprehensive, first-dollar coverages have allowed individuals to seek care without regard to cost. Provider competition and liability concerns have led to a medical technology arms race. Rather than competing on the basis of price and patient outcome, health care providers compete for patients on the basis of service, equipping themselves with the latest and best technologies. Managed-care and group-purchasing mechanisms are not widely available to small group purchasers. Health care regulation has placed undue burdens on health care insurers and providers, driving up costs, limiting competition, and preventing market-based solutions to cost and quality problems. Health care costs have been increasing at several times the rate of general inflation, eroding employer profits and investments, increasing government revenue requirements, reducing consumer coverages and purchasing power, and limiting public investments in other vital governmental services.
(2) It is the intent of the Legislature that a structured health care competition model, known as “managed competition,” be implemented throughout the state to improve the efficiency of the health care markets in this state. The managed competition model will promote the pooling of purchaser and consumer buying power; ensure informed cost-conscious consumer choice of managed care plans; reward providers for high-quality, economical care; increase access to care for uninsured persons; and control the rate of inflation in health care costs.
History.—s. 66, ch. 93-129; s. 60, ch. 2000-256; s. 11, ch. 2000-296.
408.7056 Subscriber Assistance Program.—
(1) As used in this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Department” means the Department of Financial Services.
(c) “Grievance procedure” means an established set of rules that specify a process for appeal of an organizational decision.
(d) “Health care provider” or “provider” means a state-licensed or state-authorized facility, a facility principally supported by a local government or by funds from a charitable organization that holds a current exemption from federal income tax under s. 501(c)(3) of the Internal Revenue Code, a licensed practitioner, a county health department established under part I of chapter 154, a prescribed pediatric extended care center defined in s. 400.902, a federally supported primary care program such as a migrant health center or a community health center authorized under s. 329 or s. 330 of the United States Public Health Services Act that delivers health care services to individuals, or a community facility that receives funds from the state under the Community Alcohol, Drug Abuse, and Mental Health Services Act and provides mental health services to individuals.
(e) “Managed care entity” means a health maintenance organization or a prepaid health clinic certified under chapter 641, a prepaid health plan authorized under s. 409.912, or an exclusive provider organization certified under s. 627.6472.
(f) “Office” means the Office of Insurance Regulation of the Financial Services Commission.
(g) “Panel” means a subscriber assistance panel selected as provided in subsection (11).
(2) The agency shall adopt and implement a program to provide assistance to subscribers, including those whose grievances are not resolved by the managed care entity to the satisfaction of the subscriber. The program shall consist of one or more panels that meet as often as necessary to timely review, consider, and hear grievances and recommend to the agency or the office any actions that should be taken concerning individual cases heard by the panel. The panel shall hear every grievance filed by subscribers on behalf of subscribers, unless the grievance:
(a) Relates to a managed care entity’s refusal to accept a provider into its network of providers;
(b) Is part of an internal grievance in a Medicare managed care entity or a reconsideration appeal through the Medicare appeals process which does not involve a quality of care issue;
(c) Is related to a health plan not regulated by the state such as an administrative services organization, third-party administrator, or federal employee health benefit program;
(d) Is related to appeals by in-plan suppliers and providers, unless related to quality of care provided by the plan;
(e) Is part of a Medicaid fair hearing pursued under 42 C.F.R. ss. 431.220 et seq.;
(f) Is the basis for an action pending in state or federal court;
(g) Is related to an appeal by nonparticipating providers, unless related to the quality of care provided to a subscriber by the managed care entity and the provider is involved in the care provided to the subscriber;
(h) Was filed before the subscriber completed the entire internal grievance procedure of the managed care entity, the managed care entity has complied with its timeframes for completing the internal grievance procedure, and the circumstances described in subsection (6) do not apply;
(i) Has been resolved to the satisfaction of the subscriber who filed the grievance, unless the managed care entity’s initial action is egregious or may be indicative of a pattern of inappropriate behavior;
(j) Is limited to seeking damages for pain and suffering, lost wages, or other incidental expenses, including accrued interest on unpaid balances, court costs, and transportation costs associated with a grievance procedure;
(k) Is limited to issues involving conduct of a health care provider or facility, staff member, or employee of a managed care entity which constitute grounds for disciplinary action by the appropriate professional licensing board and is not indicative of a pattern of inappropriate behavior, and the agency, office, or department has reported these grievances to the appropriate professional licensing board or to the health facility regulation section of the agency for possible investigation; or
(l) Is withdrawn by the subscriber. Failure of the subscriber to attend the hearing shall be considered a withdrawal of the grievance.
(3) The agency shall review all grievances within 60 days after receipt and make a determination whether the grievance shall be heard. Once the agency notifies the panel, the subscriber, and the managed care entity that a grievance will be heard by the panel, the panel shall hear the grievance either in the network area or by teleconference no later than 120 days after the date the grievance was filed. The agency shall notify the parties, in writing, by facsimile transmission, or by phone, of the time and place of the hearing. The panel may take testimony under oath, request certified copies of documents, and take similar actions to collect information and documentation that will assist the panel in making findings of fact and a recommendation. The panel shall issue a written recommendation, supported by findings of fact, to the subscriber, to the managed care entity, and to the agency or the office no later than 15 working days after hearing the grievance. If at the hearing the panel requests additional documentation or additional records, the time for issuing a recommendation is tolled until the information or documentation requested has been provided to the panel. The proceedings of the panel are not subject to chapter 120.
(4) If, upon receiving a proper patient authorization along with a properly filed grievance, the agency requests records from a health care provider or managed care entity, the health care provider or managed care entity that has custody of the records has 10 days to provide the records to the agency. Records include medical records, communication logs associated with the grievance both to and from the subscriber, and contracts. Failure to provide requested records may result in the imposition of a fine of up to $500. Each day that records are not produced is considered a separate violation.
(5) Grievances that the agency determines pose an immediate and serious threat to a subscriber’s health must be given priority over other grievances. The panel may meet at the call of the chair to hear the grievances as quickly as possible but no later than 45 days after the date the grievance is filed, unless the panel receives a waiver of the time requirement from the subscriber. The panel shall issue a written recommendation, supported by findings of fact, to the office or the agency within 10 days after hearing the expedited grievance.
(6) When the agency determines that the life of a subscriber is in imminent and emergent jeopardy, the chair of the panel may convene an emergency hearing, within 24 hours after notification to the managed care entity and to the subscriber, to hear the grievance. The grievance must be heard notwithstanding that the subscriber has not completed the internal grievance procedure of the managed care entity. The panel shall, upon hearing the grievance, issue a written emergency recommendation, supported by findings of fact, to the managed care entity, to the subscriber, and to the agency or the office for the purpose of deferring the imminent and emergent jeopardy to the subscriber’s life. Within 24 hours after receipt of the panel’s emergency recommendation, the agency or office may issue an emergency order to the managed care entity. An emergency order remains in force until:
(a) The grievance has been resolved by the managed care entity;
(b) Medical intervention is no longer necessary; or
(c) The panel has conducted a full hearing under subsection (3) and issued a recommendation to the agency or the office, and the agency or office has issued a final order.
(7) After hearing a grievance, the panel shall make a recommendation to the agency or the office which may include specific actions the managed care entity must take to comply with state laws or rules regulating managed care entities.
(8) A managed care entity, subscriber, or provider that is affected by a panel recommendation may within 10 days after receipt of the panel’s recommendation, or 72 hours after receipt of a recommendation in an expedited grievance, furnish to the agency or office written evidence in opposition to the recommendation or findings of fact of the panel.
(9) No later than 30 days after the issuance of the panel’s recommendation and, for an expedited grievance, no later than 10 days after the issuance of the panel’s recommendation, the agency or the office may adopt the panel’s recommendation or findings of fact in a proposed order or an emergency order, as provided in chapter 120, which it shall issue to the managed care entity. The agency or office may issue a proposed order or an emergency order, as provided in chapter 120, imposing fines or sanctions, including those contained in ss. 641.25 and 641.52. The agency or the office may reject all or part of the panel’s recommendation. All fines collected under this subsection must be deposited into the Health Care Trust Fund.
(10) In determining any fine or sanction to be imposed, the agency and the office may consider the following factors:
(a) The severity of the noncompliance, including the probability that death or serious harm to the health or safety of the subscriber will result or has resulted, the severity of the actual or potential harm, and the extent to which provisions of chapter 641 were violated.
(b) Actions taken by the managed care entity to resolve or remedy any quality-of-care grievance.
(c) Any previous incidents of noncompliance by the managed care entity.
(d) Any other relevant factors the agency or office considers appropriate in a particular grievance.
(11)(a) The panel shall consist of the Insurance Consumer Advocate, or designee thereof, established by s. 627.0613; at least two members employed by the agency and at least two members employed by the department, chosen by their respective agencies; a consumer appointed by the Governor; a physician appointed by the Governor, as a standing member; and, if necessary, physicians who have expertise relevant to the case to be heard, on a rotating basis. The agency may contract with a medical director, a primary care physician, or both, who shall provide additional technical expertise to the panel but shall not be voting members of the panel. The medical director shall be selected from a health maintenance organization with a current certificate of authority to operate in Florida.
(b) A majority of those panel members required under paragraph (a) shall constitute a quorum for any meeting or hearing of the panel. A grievance may not be heard or voted upon at any panel meeting or hearing unless a quorum is present, except that a minority of the panel may adjourn a meeting or hearing until a quorum is present. A panel convened for the purpose of hearing a subscriber’s grievance in accordance with subsections (2) and (3) shall not consist of more than 11 members.
(12) Every managed care entity shall submit a quarterly report to the agency, the office, and the department listing the number and the nature of all subscribers’ and providers’ grievances which have not been resolved to the satisfaction of the subscriber or provider after the subscriber or provider follows the entire internal grievance procedure of the managed care entity. The agency shall notify all subscribers and providers included in the quarterly reports of their right to file an unresolved grievance with the panel.
(13) A proposed order issued by the agency or office which only requires the managed care entity to take a specific action under subsection (7) is subject to a summary hearing in accordance with s. 120.574, unless all of the parties agree otherwise. If the managed care entity does not prevail at the hearing, the managed care entity must pay reasonable costs and attorney’s fees of the agency or the office incurred in that proceeding.
(14)(a) Any information that identifies a subscriber which is held by the panel, agency, or department pursuant to this section is confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. However, at the request of a subscriber or managed care entity involved in a grievance procedure, the panel, agency, or department shall release information identifying the subscriber involved in the grievance procedure to the requesting subscriber or managed care entity.
(b) Meetings of the panel shall be open to the public unless the provider or subscriber whose grievance will be heard requests a closed meeting or the agency or the department determines that information which discloses the subscriber’s medical treatment or history or information relating to internal risk management programs as defined in s. 641.55(5)(c), (6), and (8) may be revealed at the panel meeting, in which case that portion of the meeting during which a subscriber’s medical treatment or history or internal risk management program information is discussed shall be exempt from the provisions of s. 286.011 and s. 24(b), Art. I of the State Constitution. All closed meetings shall be recorded by a certified court reporter.
History.—ss. 1, 32, 47, ch. 85-177; s. 15, ch. 88-388; ss. 123, 187, 188, ch. 91-108; s. 4, ch. 91-429; s. 76, ch. 93-129; s. 23, ch. 95-398; s. 3, ch. 96-199; s. 250, ch. 96-406; s. 24, ch. 96-418; s. 1, ch. 98-10; s. 1, ch. 98-256; s. 2, ch. 99-393; s. 34, ch. 2000-256; s. 1, ch. 2000-296; s. 1, ch. 2003-105; s. 439, ch. 2003-261; s. 13, ch. 2004-297.
Note.—Former s. 641.311; (4) former s. 119.07(3)(s).
408.7057 Statewide provider and health plan claim dispute resolution program.—
(1) As used in this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Health plan” means a health maintenance organization or a prepaid health clinic certified under chapter 641, a prepaid health plan authorized under s. 409.912, an exclusive provider organization certified under s. 627.6472, or a major medical expense health insurance policy, as defined in s. 627.643(2)(e), offered by a group or an individual health insurer licensed pursuant to chapter 624, including a preferred provider organization under s. 627.6471.
(c) “Resolution organization” means a qualified independent third-party claim-dispute-resolution entity selected by and contracted with the Agency for Health Care Administration.
(2)(a) The agency shall establish a program by January 1, 2001, to provide assistance to contracted and noncontracted providers and health plans for resolution of claim disputes that are not resolved by the provider and the health plan. The agency shall contract with a resolution organization to timely review and consider claim disputes submitted by providers and health plans and recommend to the agency an appropriate resolution of those disputes. The agency shall establish by rule jurisdictional amounts and methods of aggregation for claim disputes that may be considered by the resolution organization.
(b) The resolution organization shall review claim disputes filed by contracted and noncontracted providers and health plans unless the disputed claim:
1. Is related to interest payment;
2. Does not meet the jurisdictional amounts or the methods of aggregation established by agency rule, as provided in paragraph (a);
3. Is part of an internal grievance in a Medicare managed care organization or a reconsideration appeal through the Medicare appeals process;
4. Is related to a health plan that is not regulated by the state;
5. Is part of a Medicaid fair hearing pursued under 42 C.F.R. ss. 431.220 et seq.;
6. Is the basis for an action pending in state or federal court; or
7. Is subject to a binding claim-dispute-resolution process provided by contract entered into prior to October 1, 2000, between the provider and the managed care organization.
(c) Contracts entered into or renewed on or after October 1, 2000, may require exhaustion of an internal dispute-resolution process as a prerequisite to the submission of a claim by a provider or a health plan to the resolution organization.
(d) A contracted or noncontracted provider or health plan may not file a claim dispute with the resolution organization more than 12 months after a final determination has been made on a claim by a health plan or provider.
(e) The resolution organization shall require the health plan or provider submitting the claim dispute to submit any supporting documentation to the resolution organization within 15 days after receipt by the health plan or provider of a request from the resolution organization for documentation in support of the claim dispute. The resolution organization may extend the time if appropriate. Failure to submit the supporting documentation within such time period shall result in the dismissal of the submitted claim dispute.
(f) The resolution organization shall require the respondent in the claim dispute to submit all documentation in support of its position within 15 days after receiving a request from the resolution organization for supporting documentation. The resolution organization may extend the time if appropriate. Failure to submit the supporting documentation within such time period shall result in a default against the health plan or provider. In the event of such a default, the resolution organization shall issue its written recommendation to the agency that a default be entered against the defaulting entity. The written recommendation shall include a recommendation to the agency that the defaulting entity shall pay the entity submitting the claim dispute the full amount of the claim dispute, plus all accrued interest, and shall be considered a nonprevailing party for the purposes of this section.
(g)1. If on an ongoing basis during the preceding 12 months, the agency has reason to believe that a pattern of noncompliance with s. 627.6131 and s. 641.3155 exists on the part of a particular health plan or provider, the agency shall evaluate the information contained in these cases to determine whether the information evidences a pattern and report its findings, together with substantiating evidence, to the appropriate licensure or certification entity for the health plan or provider.
2. In addition, the agency shall prepare a report to the Governor and the Legislature by February 1 of each year, enumerating: claims dismissed; defaults issued; and failures to comply with agency final orders issued under this section.
(3) The agency shall adopt rules to establish a process to be used by the resolution organization in considering claim disputes submitted by a provider or health plan which must include the issuance by the resolution organization of a written recommendation, supported by findings of fact, to the agency within 60 days after the requested information is received by the resolution organization within the timeframes specified by the resolution organization. In no event shall the review time exceed 90 days following receipt of the initial claim dispute submission by the resolution organization.
(4) Within 30 days after receipt of the recommendation of the resolution organization, the agency shall adopt the recommendation as a final order.
(5) The agency shall notify within 7 days the appropriate licensure or certification entity whenever there is a violation of a final order issued by the agency pursuant to this section.
(6) The entity that does not prevail in the agency’s order must pay a review cost to the review organization, as determined by agency rule. Such rule must provide for an apportionment of the review fee in any case in which both parties prevail in part. If the nonprevailing party fails to pay the ordered review cost within 35 days after the agency’s order, the nonpaying party is subject to a penalty of not more than $500 per day until the penalty is paid.
(7) The agency may adopt rules to administer this section.
History.—s. 8, ch. 2000-252; s. 3, ch. 2002-389.
408.7071 Standardized claim form.—The Agency for Health Care Administration shall develop a standardized claim form to be used by insurers and health care providers licensed in this state.
History.—s. 81, ch. 93-129; s. 41, ch. 97-103; s. 60, ch. 2000-158; s. 18, ch. 2000-209.
PART II
HEALTH CARE LICENSING:GENERAL PROVISIONS
408.801 Short title; purpose.
408.802 Applicability.
408.803 Definitions.
408.804 License required; display.
408.805 Fees required; adjustments.
408.806 License application process.
408.8065 Additional licensure requirements for home health agencies, home medical equipment providers, and health care clinics.
408.807 Change of ownership.
408.808 License categories.
408.809 Background screening; prohibited offenses.
408.810 Minimum licensure requirements.
408.811 Right of inspection; copies; inspection reports; plan for correction of deficiencies.
408.812 Unlicensed activity.
408.813 Administrative fines; violations.
408.814 Moratorium; emergency suspension.
408.815 License or application denial; revocation.
408.816 Injunctions.
408.817 Administrative proceedings.
408.818 Health Care Trust Fund.
408.819 Rules.
408.820 Exemptions.
408.821 Emergency management planning; emergency operations; inactive license.
408.831 Denial, suspension, or revocation of a license, registration, certificate, or application.
408.832 Conflicts.
408.801 Short title; purpose.—
(1) This part may be cited as the “Health Care Licensing Procedures Act.”
(2) The Legislature finds that there is unnecessary duplication and variation in the requirements for licensure by the agency. It is the intent of the Legislature to provide a streamlined and consistent set of basic licensing requirements for all such providers in order to minimize confusion, standardize terminology, and include issues that are otherwise not adequately addressed in the Florida Statutes pertaining to specific providers.
History.—s. 5, ch. 2006-192.
1408.802 Applicability.—The provisions of this part apply to the provision of services that require licensure as defined in this part and to the following entities licensed, registered, or certified by the agency, as described in chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765:
(1) Laboratories authorized to perform testing under the Drug-Free Workplace Act, as provided under ss. 112.0455 and 440.102.
(2) Birth centers, as provided under chapter 383.
(3) Abortion clinics, as provided under chapter 390.
(4) Crisis stabilization units, as provided under parts I and IV of chapter 394.
(5) Short-term residential treatment facilities, as provided under parts I and IV of chapter 394.
(6) Residential treatment facilities, as provided under part IV of chapter 394.
(7) Residential treatment centers for children and adolescents, as provided under part IV of chapter 394.
(8) Hospitals, as provided under part I of chapter 395.
(9) Ambulatory surgical centers, as provided under part I of chapter 395.
(10) Mobile surgical facilities, as provided under part I of chapter 395.
(11) Private review agents, as provided under part I of chapter 395.
(12) Health care risk managers, as provided under part I of chapter 395.
(13) Nursing homes, as provided under part II of chapter 400.
(14) Assisted living facilities, as provided under part I of chapter 429.
(15) Home health agencies, as provided under part III of chapter 400.
(16) Nurse registries, as provided under part III of chapter 400.
(17) Companion services or homemaker services providers, as provided under part III of chapter 400.
(18) Adult day care centers, as provided under part III of chapter 429.
(19) Hospices, as provided under part IV of chapter 400.
(20) Adult family-care homes, as provided under part II of chapter 429.
(21) Homes for special services, as provided under part V of chapter 400.
(22) Transitional living facilities, as provided under part V of chapter 400.
(23) Prescribed pediatric extended care centers, as provided under part VI of chapter 400.
(24) Home medical equipment providers, as provided under part VII of chapter 400.
(25) Intermediate care facilities for persons with developmental disabilities, as provided under part VIII of chapter 400.
(26) Health care services pools, as provided under part IX of chapter 400.
(27) Health care clinics, as provided under part X of chapter 400.
(28) Clinical laboratories, as provided under part I of chapter 483.
(29) Multiphasic health testing centers, as provided under part II of chapter 483.
(30) Organ, tissue, and eye procurement organizations, as provided under part V of chapter 765.
History.—s. 5, ch. 2006-192; s. 89, ch. 2007-5; s. 132, ch. 2007-230; s. 19, ch. 2009-218.
1Note.—Section 11, ch. 2006-192, provides that “[a]ll provisions that apply to the entities specified in s. 408.802, Florida Statutes, as created by this act, in effect on October 1, 2006, that provide for annual licensure fees are hereby adjusted to provide for biennial licensure fees with a corresponding doubling of the amount.”
408.803 Definitions.—As used in this part, the term:
(1) “Agency” means the Agency for Health Care Administration, which is the licensing agency under this part.
(2) “Applicant” means an individual, corporation, partnership, firm, association, or governmental entity that submits an application for a license to the agency.
(3) “Authorizing statute” means the statute authorizing the licensed operation of a provider listed in s. 408.802 and includes chapters 112, 383, 390, 394, 395, 400, 429, 440, 483, and 765.
(4) “Certification” means certification as a Medicare or Medicaid provider of the services that require licensure, or certification pursuant to the federal Clinical Laboratory Improvement Amendment (CLIA).
(5) “Change of ownership” means:
(a) An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or
(b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange.
A change solely in the management company or board of directors is not a change of ownership.
(6) “Client” means any person receiving services from a provider listed in s. 408.802.
(7) “Controlling interest” means:
(a) The applicant or licensee;
(b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the applicant or licensee; or
(c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the provider.
The term does not include a voluntary board member.
(8) “License” means any permit, registration, certificate, or license issued by the agency.
(9) “Licensee” means an individual, corporation, partnership, firm, association, governmental entity, or other entity that is issued a permit, registration, certificate, or license by the agency. The licensee is legally responsible for all aspects of the provider operation.
(10) “Moratorium” means a prohibition on the acceptance of new clients.
(11) “Provider” means any activity, service, agency, or facility regulated by the agency and listed in s. 408.802.
(12) “Services that require licensure” means those services, including residential services, that require a valid license before those services may be provided in accordance with authorizing statutes and agency rules.
(13) “Voluntary board member” means a board member or officer of a not-for-profit corporation or organization who serves solely in a voluntary capacity, does not receive any remuneration for his or her services on the board of directors, and has no financial interest in the corporation or organization.
History.—s. 5, ch. 2006-192; s. 90, ch. 2007-5; s. 47, ch. 2009-223.
408.804 License required; display.—
(1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider.
(2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued.
History.—s. 5, ch. 2006-192.
408.805 Fees required; adjustments.—Unless otherwise limited by authorizing statutes, license fees must be reasonably calculated by the agency to cover its costs in carrying out its responsibilities under this part, authorizing statutes, and applicable rules, including the cost of licensure, inspection, and regulation of providers.
(1) Licensure fees shall be adjusted to provide for biennial licensure under agency rules.
(2) The agency shall annually adjust licensure fees, including fees paid per bed, by not more than the change in the Consumer Price Index based on the 12 months immediately preceding the increase.
(3) An inspection fee must be paid as required in authorizing statutes.
(4) Fees are nonrefundable.
(5) When a change is reported that requires issuance of a license, a fee may be assessed. The fee must be based on the actual cost of processing and issuing the license.
(6) A fee may be charged to a licensee requesting a duplicate license. The fee may not exceed the actual cost of duplication and postage.
(7) Total fees collected may not exceed the cost of administering this part, authorizing statutes, and applicable rules.
History.—s. 5, ch. 2006-192.
408.806 License application process.—
(1) An application for licensure must be made to the agency on forms furnished by the agency, submitted under oath, and accompanied by the appropriate fee in order to be accepted and considered timely. The application must contain information required by authorizing statutes and applicable rules and must include:
(a) The name, address, and social security number of:
1. The applicant;
2. The administrator or a similarly titled person who is responsible for the day-to-day operation of the provider;
3. The financial officer or similarly titled person who is responsible for the financial operation of the licensee or provider; and
4. Each controlling interest if the applicant or controlling interest is an individual.
(b) The name, address, and federal employer identification number or taxpayer identification number of the applicant and each controlling interest if the applicant or controlling interest is not an individual.
(c) The name by which the provider is to be known.
(d) The total number of beds or capacity requested, as applicable.
(e) The name of the person or persons under whose management or supervision the provider will operate and the name of the administrator, if required.
(f) If the applicant offers continuing care agreements as defined in chapter 651, proof shall be furnished that the applicant has obtained a certificate of authority as required for operation under chapter 651.
(g) Other information, including satisfactory inspection results, that the agency finds necessary to determine the ability of the applicant to carry out its responsibilities under this part, authorizing statutes, and applicable rules.
(h) An affidavit, under penalty of perjury, as required in s. 435.05(3), stating compliance with the provisions of this section and chapter 435.
(2)(a) The applicant for a renewal license must submit an application that must be received by the agency at least 60 days but no more than 120 days before the expiration of the current license. An application received more than 120 days before the expiration of the current license shall be returned to the applicant. If the renewal application and fee are received prior to the license expiration date, the license shall not be deemed to have expired if the license expiration date occurs during the agency’s review of the renewal application.
(b) The applicant for initial licensure due to a change of ownership must submit an application that must be received by the agency at least 60 days prior to the date of change of ownership.
(c) For any other application or request, the applicant must submit an application or request that must be received by the agency at least 60 days but no more than 120 days before the requested effective date, unless otherwise specified in authorizing statutes or applicable rules. An application received more than 120 days before the requested effective date shall be returned to the applicant.
(d) The agency shall notify the licensee by mail or electronically at least 90 days before the expiration of a license that a renewal license is necessary to continue operation. The failure to timely submit a renewal application and license fee shall result in a $50 per day late fee charged to the licensee by the agency; however, the aggregate amount of the late fee may not exceed 50 percent of the licensure fee or $500, whichever is less. If an application is received after the required filing date and exhibits a hand-canceled postmark obtained from a United States post office dated on or before the required filing date, no fine will be levied.
(3)(a) Upon receipt of an application for a license, the agency shall examine the application and, within 30 days after receipt, notify the applicant in writing of any apparent errors or omissions and request any additional information required.
(b) Requested information omitted from an application for licensure, license renewal, or change of ownership, other than an inspection, must be filed with the agency within 21 days after the agency’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited.
(c) Within 60 days after the receipt of a complete application, the agency shall approve or deny the application.
(4)(a) Licensees subject to the provisions of this part shall be issued biennial licenses unless conditions of the license category specify a shorter license period.
(b) Each license issued shall indicate the name of the licensee, the type of provider or service that the licensee is required or authorized to operate or offer, the date the license is effective, the expiration date of the license, the maximum capacity of the licensed premises, if applicable, and any other information required or deemed necessary by the agency.
(5) In accordance with authorizing statutes and applicable rules, proof of compliance with s. 408.810 must be submitted with an application for licensure.
(6) The agency may not issue an initial license to a health care provider subject to the certificate-of-need provisions in part I of this chapter if the licensee has not been issued a certificate of need or certificate-of-need exemption, when applicable. Failure to apply for the renewal of a license prior to the expiration date renders the license void.
(7)(a) An applicant must demonstrate compliance with the requirements in this part, authorizing statutes, and applicable rules during an inspection pursuant to s. 408.811, as required by authorizing statutes.
(b) An initial inspection is not required for companion services or homemaker services providers, as provided under part III of chapter 400, or for health care services pools, as provided under part IX of chapter 400.
(c) If an inspection is required by the authorizing statute for a license application other than an initial application, the inspection must be unannounced. This paragraph does not apply to inspections required pursuant to ss. 383.324, 395.0161(4), 429.67(6), and 483.061(2).
(d) If a provider is not available when an inspection is attempted, the application shall be denied.
(8) The agency may establish procedures for the electronic notification and submission of required information, including, but not limited to:
(a) Licensure applications.
(b) Required signatures.
(c) Payment of fees.
(d) Notarization of applications.
Requirements for electronic submission of any documents required by this part or authorizing statutes may be established by rule. As an alternative to sending documents as required by authorizing statutes, the agency may provide electronic access to information or documents.
History.—s. 5, ch. 2006-192; s. 91, ch. 2007-5; s. 48, ch. 2009-223; s. 19, ch. 2010-114.
408.8065 Additional licensure requirements for home health agencies, home medical equipment providers, and health care clinics.—
(1) An applicant for initial licensure, or initial licensure due to a change of ownership, as a home health agency, home medical equipment provider, or health care clinic shall:
(a) Demonstrate financial ability to operate, as required under s. 408.810(8) and this section. If the applicant’s assets, credit, and projected revenues meet or exceed projected liabilities and expenses, and the applicant provides independent evidence that the funds necessary for startup costs, working capital, and contingency financing exist and will be available as needed, the applicant has demonstrated the financial ability to operate.
(b) Submit pro forma financial statements, including a balance sheet, income and expense statement, and a statement of cash flows for the first 2 years of operation which provide evidence that the applicant has sufficient assets, credit, and projected revenues to cover liabilities and expenses.
(c) Submit a statement of the applicant’s estimated startup costs and sources of funds through the break-even point in operations demonstrating that the applicant has the ability to fund all startup costs, working capital 1costs, and contingency financing 2requirements. The statement must show that the applicant has at a minimum 3 months of average projected expenses to cover startup costs, working capital 1costs, and contingency financing 2requirements. The minimum amount for contingency funding may not be less than 1 month of average projected expenses.
All documents required under this subsection must be prepared in accordance with generally accepted accounting principles and may be in a compilation form. The financial statements must be signed by a certified public accountant.
(2) For initial, renewal, or change of ownership licenses for a home health agency, a home medical equipment provider, or a health care clinic, applicants and controlling interests who are nonimmigrant aliens, as described in 8 U.S.C. s. 1101, must file a surety bond of at least $500,000, payable to the agency, which guarantees that the home health agency, home medical equipment provider, or health care clinic will act in full conformity with all legal requirements for operation.
(3) In addition to the requirements of s. 408.812, any person who offers services that require licensure under part VII or part X of chapter 400, or who offers skilled services that require licensure under part III of chapter 400, without obtaining a valid license; any person who knowingly files a false or misleading license or license renewal application or who submits false or misleading information related to such application, and any person who violates or conspires to violate this section, commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
History.—s. 4, ch. 2009-193; s. 8, ch. 2009-223.
1Note.—As created by s. 4, ch. 2009-193. Section 8, ch. 2009-223, also created s. 408.8065, and that version did not include the word “costs.”
2Note.—As created by s. 4, ch. 2009-193. Section 8, ch. 2009-223, also created s. 408.8065, and that version did not include the word “requirements.”
408.807 Change of ownership.—Whenever a change of ownership occurs:
(1) The transferor shall notify the agency in writing at least 60 days before the anticipated date of the change of ownership.
(2) The transferee shall make application to the agency for a license within the timeframes required in s. 408.806.
(3) The transferor shall be responsible and liable for:
(a) The lawful operation of the provider and the welfare of the clients served until the date the transferee is licensed by the agency.
(b) Any and all penalties imposed against the transferor for violations occurring before the date of change of ownership.
(4) Any restriction on licensure, including a conditional license existing at the time of a change of ownership, shall remain in effect until the agency determines that the grounds for the restriction are corrected.
(5) The transferee shall maintain records of the transferor as required in this part, authorizing statutes, and applicable rules, including:
(a) All client records.
(b) Inspection reports.
(c) All records required to be maintained pursuant to s. 409.913, if applicable.
History.—s. 5, ch. 2006-192.
408.808 License categories.—
(1) STANDARD LICENSE.—A standard license may be issued to an applicant at the time of initial licensure, license renewal, or change of ownership. A standard license shall be issued when the applicant is in compliance with all statutory requirements and agency rules. Unless sooner revoked, a standard license expires 2 years after the date of issue.
(2) PROVISIONAL LICENSE.—An applicant against whom a proceeding denying or revoking a license is pending at the time of license renewal may be issued a provisional license effective until final action not subject to further appeal. A provisional license may also be issued to an applicant applying for a change of ownership. A provisional license must be limited in duration to a specific period of time, up to 12 months, as determined by the agency.
(3) INACTIVE LICENSE.—An inactive license may be issued to a health care provider subject to the certificate-of-need provisions in part I of this chapter when the provider is currently licensed, does not have a provisional license, and will be temporarily unable to provide services but is reasonably expected to resume services within 12 months. Such designation may be made for a period not to exceed 12 months but may be renewed by the agency for up to 12 additional months upon demonstration by the licensee of the provider’s progress toward reopening. However, if after 20 months in an inactive license status, a statutory rural hospital, as defined in s. 395.602, has demonstrated progress toward reopening, but may not be able to reopen prior to the inactive license expiration date, the inactive designation may be renewed again by the agency for up to 12 additional months. For purposes of such a second renewal, if construction or renovation is required, the licensee must have had plans approved by the agency and construction must have already commenced pursuant to s. 408.032(4); however, if construction or renovation is not required, the licensee must provide proof of having made an enforceable capital expenditure greater than 25 percent of the total costs associated with the hiring of staff and the purchase of equipment and supplies needed to operate the facility upon opening. A request by a licensee for an inactive license or to extend the previously approved inactive period must be submitted to the agency and must include a written justification for the inactive license with the beginning and ending dates of inactivity specified, a plan for the transfer of any clients to other providers, and the appropriate licensure fees. The agency may not accept a request that is submitted after initiating closure, after any suspension of service, or after notifying clients of closure or suspension of service, unless the action is a result of a disaster at the licensed premises. For the purposes of this section, the term “disaster” means a sudden emergency occurrence beyond the control of the licensee, whether natural, technological, or manmade, which renders the provider inoperable at the premises. Upon agency approval, the provider shall notify clients of any necessary discharge or transfer as required by authorizing statutes or applicable rules. The beginning of the inactive license period is the date the provider ceases operations. The end of the inactive license period shall become the license expiration date. All licensure fees must be current, must be paid in full, and may be prorated. Reactivation of an inactive license requires the approval of a renewal application, including payment of licensure fees and agency inspections indicating compliance with all requirements of this part, authorizing statutes, and applicable rules.
(4) OTHER LICENSES.—Other types of license categories may be issued pursuant to authorizing statutes or applicable rules.
History.—s. 5, ch. 2006-192; s. 2, ch. 2009-45; s. 49, ch. 2009-223; s. 20, ch. 2010-114.
408.809 Background screening; prohibited offenses.—
(1) Level 2 background screening pursuant to chapter 435 must be conducted through the agency on each of the following persons, who are considered employees for the purposes of conducting screening under chapter 435:
(a) The licensee, if an individual.
(b) The administrator or a similarly titled person who is responsible for the day-to-day operation of the provider.
(c) The financial officer or similarly titled individual who is responsible for the financial operation of the licensee or provider.
(d) Any person who is a controlling interest if the agency has reason to believe that such person has been convicted of any offense prohibited by s. 435.04. For each controlling interest who has been convicted of any such offense, the licensee shall submit to the agency a description and explanation of the conviction at the time of license application.
(e) Any person, as required by authorizing statutes, seeking employment with a licensee or provider who is expected to, or whose responsibilities may require him or her to, provide personal care or services directly to clients or have access to client funds, personal property, or living areas; and any person, as required by authorizing statutes, contracting with a licensee or provider whose responsibilities require him or her to provide personal care or personal services directly to clients. Evidence of contractor screening may be retained by the contractor’s employer or the licensee.
(2) Every 5 years following his or her licensure, employment, or entry into a contract in a capacity that under subsection (1) would require level 2 background screening under chapter 435, each such person must submit to level 2 background rescreening as a condition of retaining such license or continuing in such employment or contractual status. For any such rescreening, the agency shall request the Department of Law Enforcement to forward the person’s fingerprints to the Federal Bureau of Investigation for a national criminal history record check. If the fingerprints of such a person are not retained by the Department of Law Enforcement under s. 943.05(2)(g), the person must file a complete set of fingerprints with the agency and the agency shall forward the fingerprints to the Department of Law Enforcement for state processing, and the Department of Law Enforcement shall forward the fingerprints to the Federal Bureau of Investigation for a national criminal history record check. The fingerprints may be retained by the Department of Law Enforcement under s. 943.05(2)(g). The cost of the state and national criminal history records checks required by level 2 screening may be borne by the licensee or the person fingerprinted. Proof of compliance with level 2 screening standards submitted within the previous 5 years to meet any provider or professional licensure requirements of the agency, the Department of Health, the Agency for Persons with Disabilities, the Department of Children and Family Services, or the Department of Financial Services for an applicant for a certificate of authority or provisional certificate of authority to operate a continuing care retirement community under chapter 651 satisfies the requirements of this section if the person subject to screening has not been unemployed for more than 90 days and such proof is accompanied, under penalty of perjury, by an affidavit of compliance with the provisions of chapter 435 and this section using forms provided by the agency.
(3) All fingerprints must be provided in electronic format. Screening results shall be reviewed by the agency with respect to the offenses specified in s. 435.04 and this section, and the qualifying or disqualifying status of the person named in the request shall be maintained in a database. The qualifying or disqualifying status of the person named in the request shall be posted on a secure website for retrieval by the licensee or designated agent on the licensee’s behalf.
(4) In addition to the offenses listed in s. 435.04, all persons required to undergo background screening pursuant to this part or authorizing statutes must not have an arrest awaiting final disposition for, must not have been found guilty of, regardless of adjudication, or entered a plea of nolo contendere or guilty to, and must not have been adjudicated delinquent and the record not have been sealed or expunged for any of the following offenses or any similar offense of another jurisdiction:
(a) Any authorizing statutes, if the offense was a felony.
(b) This chapter, if the offense was a felony.
(c) Section 409.920, relating to Medicaid provider fraud.
(d) Section 409.9201, relating to Medicaid fraud.
(e) Section 741.28, relating to domestic violence.
(f) Section 817.034, relating to fraudulent acts through mail, wire, radio, electromagnetic, photoelectronic, or photooptical systems.
(g) Section 817.234, relating to false and fraudulent insurance claims.
(h) Section 817.505, relating to patient brokering.
(i) Section 817.568, relating to criminal use of personal identification information.
(j) Section 817.60, relating to obtaining a credit card through fraudulent means.
(k) Section 817.61, relating to fraudulent use of credit cards, if the offense was a felony.
(l) Section 831.01, relating to forgery.
(m) Section 831.02, relating to uttering forged instruments.
(n) Section 831.07, relating to forging bank bills, checks, drafts, or promissory notes.
(o) Section 831.09, relating to uttering forged bank bills, checks, drafts, or promissory notes.
(p) Section 831.30, relating to fraud in obtaining medicinal drugs.
(q) Section 831.31, relating to the sale, manufacture, delivery, or possession with the intent to sell, manufacture, or deliver any counterfeit controlled substance, if the offense was a felony.
A person who serves as a controlling interest of, is employed by, or contracts with a licensee on July 31, 2010, who has been screened and qualified according to standards specified in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015. The agency may adopt rules to establish a schedule to stagger the implementation of the required rescreening over the 5-year period, beginning July 31, 2010, through July 31, 2015. If, upon rescreening, such person has a disqualifying offense that was not a disqualifying offense at the time of the last screening, but is a current disqualifying offense and was committed before the last screening, he or she may apply for an exemption from the appropriate licensing agency and, if agreed to by the employer, may continue to perform his or her duties until the licensing agency renders a decision on the application for exemption if the person is eligible to apply for an exemption and the exemption request is received by the agency within 30 days after receipt of the rescreening results by the person.
(5) The costs associated with obtaining the required screening must be borne by the licensee or the person subject to screening. Licensees may reimburse persons for these costs. The Department of Law Enforcement shall charge the agency for screening pursuant to s. 943.053(3). The agency shall establish a schedule of fees to cover the costs of screening.
(6)(a) As provided in chapter 435, the agency may grant an exemption from disqualification to a person who is subject to this section and who:
1. Does not have an active professional license or certification from the Department of Health; or
2. Has an active professional license or certification from the Department of Health but is not providing a service within the scope of that license or certification.
(b) As provided in chapter 435, the appropriate regulatory board within the Department of Health, or the department itself if there is no board, may grant an exemption from disqualification to a person who is subject to this section and who has received a professional license or certification from the Department of Health or a regulatory board within that department and that person is providing a service within the scope of his or her licensed or certified practice.
(7) The agency and the Department of Health may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this section, chapter 435, and authorizing statutes requiring background screening and to implement and adopt criteria relating to retaining fingerprints pursuant to s. 943.05(2).
(8) There is no unemployment compensation or other monetary liability on the part of, and no cause of action for damages arising against, an employer that, upon notice of a disqualifying offense listed under chapter 435 or this section, terminates the person against whom the report was issued, whether or not that person has filed for an exemption with the Department of Health or the agency.
History.—s. 5, ch. 2006-192; s. 50, ch. 2009-223; s. 21, ch. 2010-114.
408.810 Minimum licensure requirements.—In addition to the licensure requirements specified in this part, authorizing statutes, and applicable rules, each applicant and licensee must comply with the requirements of this section in order to obtain and maintain a license.
(1) An applicant for licensure must comply with the background screening requirements of s. 408.809.
(2) An applicant for licensure must provide a description and explanation of any exclusions, suspensions, or terminations of the applicant from the Medicare, Medicaid, or federal Clinical Laboratory Improvement Amendment (CLIA) programs.
(3) Unless otherwise specified in this part, authorizing statutes, or applicable rules, any information required to be reported to the agency must be submitted within 21 calendar days after the report period or effective date of the information, whichever is earlier, including, but not limited to, any change of:
(a) Information contained in the most recent application for licensure.
(b) Required insurance or bonds.
(4) Whenever a licensee discontinues operation of a provider:
(a) The licensee must inform the agency not less than 30 days prior to the discontinuance of operation and inform clients of such discontinuance as required by authorizing statutes. Immediately upon discontinuance of operation by a provider, the licensee shall surrender the license to the agency and the license shall be canceled.
(b) The licensee shall remain responsible for retaining and appropriately distributing all records within the timeframes prescribed in authorizing statutes and applicable rules. In addition, the licensee or, in the event of death or dissolution of a licensee, the estate or agent of the licensee shall:
1. Make arrangements to forward records for each client to one of the following, based upon the client’s choice: the client or the client’s legal representative, the client’s attending physician, or the health care provider where the client currently receives services; or
2. Cause a notice to be published in the newspaper of greatest general circulation in the county in which the provider was located that advises clients of the discontinuance of the provider operation. The notice must inform clients that they may obtain copies of their records and specify the name, address, and telephone number of the person from whom the copies of records may be obtained. The notice must appear at least once a week for 4 consecutive weeks.
(5)(a) On or before the first day services are provided to a client, a licensee must inform the client and his or her immediate family or representative, if appropriate, of the right to report:
1. Complaints. The statewide toll-free telephone number for reporting complaints to the agency must be provided to clients in a manner that is clearly legible and must include the words: “To report a complaint regarding the services you receive, please call toll-free (phone number).”
2. Abusive, neglectful, or exploitative practices. The statewide toll-free telephone number for the central abuse hotline must be provided to clients in a manner that is clearly legible and must include the words: “To report abuse, neglect, or exploitation, please call toll-free (phone number).”
3. Medicaid fraud. An agency-written description of Medicaid fraud and the statewide toll-free telephone number for the central Medicaid fraud hotline must be provided to clients in a manner that is clearly legible and must include the words: “To report suspected Medicaid fraud, please call toll-free (phone number).”
The agency shall publish a minimum of a 90-day advance notice of a change in the toll-free telephone numbers.
(b) Each licensee shall establish appropriate policies and procedures for providing such notice to clients.
(6) An applicant must provide the agency with proof of the applicant’s legal right to occupy the property before a license may be issued. Proof may include, but need not be limited to, copies of warranty deeds, lease or rental agreements, contracts for deeds, quitclaim deeds, or other such documentation.
(7) If proof of insurance is required by the authorizing statute, that insurance must be in compliance with chapter 624, chapter 626, chapter 627, or chapter 628 and with agency rules.
(8) Upon application for initial licensure or change of ownership licensure, the applicant shall furnish satisfactory proof of the applicant’s financial ability to operate in accordance with the requirements of this part, authorizing statutes, and applicable rules. The agency shall establish standards for this purpose, including information concerning the applicant’s controlling interests. The agency shall also establish documentation requirements, to be completed by each applicant, that show anticipated provider revenues and expenditures, the basis for financing the anticipated cash-flow requirements of the provider, and an applicant’s access to contingency financing. A current certificate of authority, pursuant to chapter 651, may be provided as proof of financial ability to operate. The agency may require a licensee to provide proof of financial ability to operate at any time if there is evidence of financial instability, including, but not limited to, unpaid expenses necessary for the basic operations of the provider.
(9) A controlling interest may not withhold from the agency any evidence of financial instability, including, but not limited to, checks returned due to insufficient funds, delinquent accounts, nonpayment of withholding taxes, unpaid utility expenses, nonpayment for essential services, or adverse court action concerning the financial viability of the provider or any other provider licensed under this part that is under the control of the controlling interest. Any person who violates this subsection commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Each day of continuing violation is a separate offense.
(10) The agency may not issue a license to a health care provider subject to the certificate-of-need provisions in part I of this chapter if the health care provider has not been issued a certificate of need or an exemption. Upon initial licensure of any such provider, the authorization contained in the certificate of need shall be considered fully implemented and merged into the license and shall have no force and effect upon termination of the license for any reason.
History.—s. 5, ch. 2006-192; s. 9, ch. 2009-223.
408.811 Right of inspection; copies; inspection reports; plan for correction of deficiencies.—
(1) An authorized officer or employee of the agency may make or cause to be made any inspection or investigation deemed necessary by the agency to determine the state of compliance with this part, authorizing statutes, and applicable rules. The right of inspection extends to any business that the agency has reason to believe is being operated as a provider without a license, but inspection of any business suspected of being operated without the appropriate license may not be made without the permission of the owner or person in charge unless a warrant is first obtained from a circuit court. Any application for a license issued under this part, authorizing statutes, or applicable rules constitutes permission for an appropriate inspection to verify the information submitted on or in connection with the application.
(a) All inspections shall be unannounced, except as specified in s. 408.806.
(b) Inspections for relicensure shall be conducted biennially unless otherwise specified by authorizing statutes or applicable rules.
(2) Inspections conducted in conjunction with certification, comparable licensure requirements, or a recognized or approved accreditation organization may be accepted in lieu of a complete licensure inspection. However, a licensure inspection may also be conducted to review any licensure requirements that are not also requirements for certification.
(3) The agency shall have access to and the licensee shall provide, or if requested send, copies of all provider records required during an inspection or other review at no cost to the agency, including records requested during an offsite review.
(4) A deficiency must be corrected within 30 calendar days after the provider is notified of inspection results unless an alternative timeframe is required or approved by the agency.
(5) The agency may require an applicant or licensee to submit a plan of correction for deficiencies. If required, the plan of correction must be filed with the agency within 10 calendar days after notification unless an alternative timeframe is required.
(6)(a) Each licensee shall maintain as public information, available upon request, records of all inspection reports pertaining to that provider that have been filed by the agency unless those reports are exempt from or contain information that is exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution or is otherwise made confidential by law. Effective October 1, 2006, copies of such reports shall be retained in the records of the provider for at least 3 years following the date the reports are filed and issued, regardless of a change of ownership.
(b) A licensee shall, upon the request of any person who has completed a written application with intent to be admitted by such provider, any person who is a client of such provider, or any relative, spouse, or guardian of any such person, furnish to the requester a copy of the last inspection report pertaining to the licensed provider that was issued by the agency or by an accrediting organization if such report is used in lieu of a licensure inspection.
History.—s. 5, ch. 2006-192; s. 51, ch. 2009-223.
408.812 Unlicensed activity.—
(1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license.
(2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency.
(3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense.
(4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of noncompliance.
(5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation.
(6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules.
(7) Any person aware of the operation of an unlicensed provider must report that provider to the agency.
History.—s. 5, ch. 2006-192.
408.813 Administrative fines; violations.—As a penalty for any violation of this part, authorizing statutes, or applicable rules, the agency may impose an administrative fine.
(1) Unless the amount or aggregate limitation of the fine is prescribed by authorizing statutes or applicable rules, the agency may establish criteria by rule for the amount or aggregate limitation of administrative fines applicable to this part, authorizing statutes, and applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. For fines imposed by final order of the agency and not subject to further appeal, the violator shall pay the fine plus interest at the rate specified in s. 55.03 for each day beyond the date set by the agency for payment of the fine.
(2) Violations of this part, authorizing statutes, or applicable rules shall be classified according to the nature of the violation and the gravity of its probable effect on clients. The scope of a violation may be cited as an isolated, patterned, or widespread deficiency. An isolated deficiency is a deficiency affecting one or a very limited number of clients, or involving one or a very limited number of staff, or a situation that occurred only occasionally or in a very limited number of locations. A patterned deficiency is a deficiency in which more than a very limited number of clients are affected, or more than a very limited number of staff are involved, or the situation has occurred in several locations, or the same client or clients have been affected by repeated occurrences of the same deficient practice but the effect of the deficient practice is not found to be pervasive throughout the provider. A widespread deficiency is a deficiency in which the problems causing the deficiency are pervasive in the provider or represent systemic failure that has affected or has the potential to affect a large portion of the provider’s clients. This subsection does not affect the legislative determination of the amount of a fine imposed under authorizing statutes. Violations shall be classified on the written notice as follows:
(a) Class “I” violations are those conditions or occurrences related to the operation and maintenance of a provider or to the care of clients which the agency determines present an imminent danger to the clients of the provider or a substantial probability that death or serious physical or emotional harm would result therefrom. The condition or practice constituting a class I violation shall be abated or eliminated within 24 hours, unless a fixed period, as determined by the agency, is required for correction. The agency shall impose an administrative fine as provided by law for a cited class I violation. A fine shall be levied notwithstanding the correction of the violation.
(b) Class “II” violations are those conditions or occurrences related to the operation and maintenance of a provider or to the care of clients which the agency determines directly threaten the physical or emotional health, safety, or security of the clients, other than class I violations. The agency shall impose an administrative fine as provided by law for a cited class II violation. A fine shall be levied notwithstanding the correction of the violation.
(c) Class “III” violations are those conditions or occurrences related to the operation and maintenance of a provider or to the care of clients which the agency determines indirectly or potentially threaten the physical or emotional health, safety, or security of clients, other than class I or class II violations. The agency shall impose an administrative fine as provided in this section for a cited class III violation. A citation for a class III violation must specify the time within which the violation is required to be corrected. If a class III violation is corrected within the time specified, a fine may not be imposed.
(d) Class “IV” violations are those conditions or occurrences related to the operation and maintenance of a provider or to required reports, forms, or documents that do not have the potential of negatively affecting clients. These violations are of a type that the agency determines do not threaten the health, safety, or security of clients. The agency shall impose an administrative fine as provided in this section for a cited class IV violation. A citation for a class IV violation must specify the time within which the violation is required to be corrected. If a class IV violation is corrected within the time specified, a fine may not be imposed.
History.—s. 5, ch. 2006-192; s. 52, ch. 2009-223.
408.814 Moratorium; emergency suspension.—
(1) The agency may impose an immediate moratorium or emergency suspension as defined in s. 120.60 on any provider if the agency determines that any condition related to the provider or licensee presents a threat to the health, safety, or welfare of a client.
(2) A provider or licensee, the license of which is denied or revoked, may be subject to immediate imposition of a moratorium or emergency suspension to run concurrently with licensure denial, revocation, or injunction.
(3) A moratorium or emergency suspension remains in effect after a change of ownership, unless the agency has determined that the conditions that created the moratorium, emergency suspension, or denial of licensure have been corrected.
(4) When a moratorium or emergency suspension is placed on a provider or licensee, notice of the action shall be posted and visible to the public at the location of the provider until the action is lifted.
History.—s. 5, ch. 2006-192.
408.815 License or application denial; revocation.—
(1) In addition to the grounds provided in authorizing statutes, grounds that may be used by the agency for denying and revoking a license or change of ownership application include any of the following actions by a controlling interest:
(a) False representation of a material fact in the license application or omission of any material fact from the application.
(b) An intentional or negligent act materially affecting the health or safety of a client of the provider.
(c) A violation of this part, authorizing statutes, or applicable rules.
(d) A demonstrated pattern of deficient performance.
(e) The applicant, licensee, or controlling interest has been or is currently excluded, suspended, or terminated from participation in the state Medicaid program, the Medicaid program of any other state, or the Medicare program.
(2) If a licensee lawfully continues to operate while a denial or revocation is pending in litigation, the licensee must continue to meet all other requirements of this part, authorizing statutes, and applicable rules and file subsequent renewal applications for licensure and pay all licensure fees. The provisions of ss. 120.60(1) and 408.806(3)(c) do not apply to renewal applications filed during the time period in which the litigation of the denial or revocation is pending until that litigation is final.
(3) An action under s. 408.814 or denial of the license of the transferor may be grounds for denial of a change of ownership application of the transferee.
(4) Unless an applicant is determined by the agency to satisfy the provisions of subsection (5) for the action in question, the agency shall deny an application for a license or license renewal based upon any of the following actions of an applicant, a controlling interest of the applicant, or any entity in which a controlling interest of the applicant was an owner or officer when the following actions occurred:
(a) A conviction or a plea of guilty or nolo contendere to, regardless of adjudication, a felony under chapter 409, chapter 817, chapter 893, 21 U.S.C. ss. 801-970, or 42 U.S.C. ss. 1395-1396, Medicaid fraud, Medicare fraud, or insurance fraud, unless the sentence and any subsequent period of probation for such convictions or plea ended more than 15 years before the date of the application; or
(b) Termination for cause from the Medicare program or a state Medicaid program, unless the applicant has been in good standing with the Medicare program or a state Medicaid program for the most recent 5 years and the termination occurred at least 20 years before the date of the application.
(5) For any application subject to denial under subsection (4), the agency may consider mitigating circumstances as applicable, including, but not limited to:
(a) Completion or lawful release from confinement, supervision, or sanction, including the terms of probation, and full restitution;
(b) Execution of a compliance plan with the agency;
(c) Compliance with an integrity agreement or compliance plan with another government agency;
(d) Determination by any state Medicaid program or the Medicare program that the controlling interest or entity in which the controlling interest was an owner or officer is currently allowed to participate in the state Medicaid program or the Medicare program, directly as a provider or indirectly as an owner or officer of a provider entity;
(e) Continuation of licensure by the controlling interest or entity in which the controlling interest was an owner or officer, directly as a licensee or indirectly as an owner or officer of a licensed entity in the state where the action occurred;
(f) Overall impact upon the public health, safety, or welfare; or
(g) Determination that a license denial is not commensurate with the prior action taken by the Medicare or state Medicaid program.
After considering the circumstances set forth in this subsection, the agency shall grant the license, with or without conditions, grant a provisional license for a period of no more than the licensure cycle, with or without conditions, or deny the license.
(6) In order to ensure the health, safety, and welfare of clients when a license has been denied, revoked, or is set to terminate, the agency may extend the license expiration date for up to 30 days for the sole purpose of allowing the safe and orderly discharge of clients. The agency may impose conditions on the extension, including, but not limited to, prohibiting or limiting admissions, expedited discharge planning, required status reports, and mandatory monitoring by the agency or third parties. When imposing these conditions, the agency shall consider the nature and number of clients, the availability and location of acceptable alternative placements, and the ability of the licensee to continue providing care to the clients. The agency may terminate the extension or modify the conditions at any time. This authority is in addition to any other authority granted to the agency under chapter 120, this part, and authorizing statutes but creates no right or entitlement to an extension of a license expiration date.
History.—s. 5, ch. 2006-192; s. 10, ch. 2009-223; s. 2, ch. 2011-61.
408.816 Injunctions.—
(1) In addition to the other powers provided by this part, authorizing statutes, and applicable rules, the agency may institute injunction proceedings in a court of competent jurisdiction to:
(a) Restrain or prevent the establishment or operation of a provider that does not have a license or is in violation of any provision of this part, authorizing statutes, or applicable rules. The agency may also institute injunction proceedings in a court of competent jurisdiction when a violation of this part, authorizing statutes, or applicable rules constitutes an emergency affecting the immediate health and safety of a client.
(b) Enforce the provisions of this part, authorizing statutes, or any minimum standard, rule, or order issued or entered into pursuant thereto when the attempt by the agency to correct a violation through administrative sanctions has failed or when the violation materially affects the health, safety, or welfare of clients or involves any operation of an unlicensed provider.
(c) Terminate the operation of a provider when a violation of any provision of this part, authorizing statutes, or any standard or rule adopted pursuant thereto exists that materially affects the health, safety, or welfare of a client.
Such injunctive relief may be temporary or permanent.
(2) If action is necessary to protect clients of providers from immediate, life-threatening situations, the court may allow a temporary injunction without bond upon proper proofs being made. If it appears by competent evidence or a sworn, substantiated affidavit that a temporary injunction should be issued, the court, pending the determination on final hearing, shall enjoin the operation of the provider.
History.—s. 5, ch. 2006-192.
408.817 Administrative proceedings.—Administrative proceedings challenging agency licensure enforcement action shall be reviewed on the basis of the facts and conditions that resulted in the agency action.
History.—s. 5, ch. 2006-192.
408.818 Health Care Trust Fund.—Unless otherwise prescribed by authorizing statutes, all fees and fines collected under this part, authorizing statutes, and applicable rules shall be deposited into the Health Care Trust Fund, created in s. 408.16, and used to pay the costs of the agency in administering the provider program paying the fees or fines.
History.—s. 5, ch. 2006-192.
408.819 Rules.—The agency is authorized to adopt rules as necessary to administer this part. Any licensed provider that is in operation at the time of adoption of any applicable rule under this part or authorizing statutes shall be given a reasonable time under the particular circumstances, not to exceed 6 months after the date of such adoption, within which to comply with such rule, unless otherwise specified by rule.
History.—s. 5, ch. 2006-192.
408.820 Exemptions.—Except as prescribed in authorizing statutes, the following exemptions shall apply to specified requirements of this part:
(1) Laboratories authorized to perform testing under the Drug-Free Workplace Act, as provided under ss. 112.0455 and 440.102, are exempt from s. 408.810(5)-(10).
(2) Birth centers, as provided under chapter 383, are exempt from s. 408.810(7)-(10).
(3) Abortion clinics, as provided under chapter 390, are exempt from s. 408.810(7)-(10).
(4) Crisis stabilization units, as provided under parts I and IV of chapter 394, are exempt from s. 408.810(8)-(10).
(5) Short-term residential treatment facilities, as provided under parts I and IV of chapter 394, are exempt from s. 408.810(8)-(10).
(6) Residential treatment facilities, as provided under part IV of chapter 394, are exempt from s. 408.810(8)-(10).
(7) Residential treatment centers for children and adolescents, as provided under part IV of chapter 394, are exempt from s. 408.810(8)-(10).
(8) Hospitals, as provided under part I of chapter 395, are exempt from s. 408.810(7)-(9).
(9) Ambulatory surgical centers, as provided under part I of chapter 395, are exempt from s. 408.810(7)-(10).
(10) Mobile surgical facilities, as provided under part I of chapter 395, are exempt from s. 408.810(7)-(10).
(11) Health care risk managers, as provided under part I of chapter 395, are exempt from ss. 408.806(7), 408.810(4)-(10), and 408.811.
(12) Nursing homes, as provided under part II of chapter 400, are exempt from ss. 408.810(7) and 408.813(2).
(13) Assisted living facilities, as provided under part I of chapter 429, are exempt from s. 408.810(10).
(14) Home health agencies, as provided under part III of chapter 400, are exempt from s. 408.810(10).
(15) Nurse registries, as provided under part III of chapter 400, are exempt from s. 408.810(6) and (10).
(16) Companion services or homemaker services providers, as provided under part III of chapter 400, are exempt from s. 408.810(6)-(10).
(17) Adult day care centers, as provided under part III of chapter 429, are exempt from s. 408.810(10).
(18) Adult family-care homes, as provided under part II of chapter 429, are exempt from s. 408.810(7)-(10).
(19) Homes for special services, as provided under part V of chapter 400, are exempt from s. 408.810(7)-(10).
(20) Transitional living facilities, as provided under part V of chapter 400, are exempt from s. 408.810(10).
(21) Prescribed pediatric extended care centers, as provided under part VI of chapter 400, are exempt from s. 408.810(10).
(22) Home medical equipment providers, as provided under part VII of chapter 400, are exempt from s. 408.810(10).
(23) Intermediate care facilities for persons with developmental disabilities, as provided under part VIII of chapter 400, are exempt from s. 408.810(7).
(24) Health care services pools, as provided under part IX of chapter 400, are exempt from s. 408.810(6)-(10).
(25) Health care clinics, as provided under part X of chapter 400, are exempt from s. 408.810(6), (7), and (10).
(26) Clinical laboratories, as provided under part I of chapter 483, are exempt from s. 408.810(5)-(10).
(27) Multiphasic health testing centers, as provided under part II of chapter 483, are exempt from s. 408.810(5)-(10).
(28) Organ, tissue, and eye procurement organizations, as provided under part V of chapter 765, are exempt from s. 408.810(5)-(10).
History.—s. 5, ch. 2006-192; s. 92, ch. 2007-5; s. 20, ch. 2009-218; s. 53, ch. 2009-223; s. 90, ch. 2010-5.
408.821 Emergency management planning; emergency operations; inactive license.—
(1) A licensee required by authorizing statutes to have an emergency operations plan must designate a safety liaison to serve as the primary contact for emergency operations.
(2) An entity subject to this part may temporarily exceed its licensed capacity to act as a receiving provider in accordance with an approved emergency operations plan for up to 15 days. While in an overcapacity status, each provider must furnish or arrange for appropriate care and services to all clients. In addition, the agency may approve requests for overcapacity in excess of 15 days, which approvals may be based upon satisfactory justification and need as provided by the receiving and sending providers.
(3)(a) An inactive license may be issued to a licensee subject to this section when the provider is located in a geographic area in which a state of emergency was declared by the Governor if the provider:
1. Suffered damage to its operation during the state of emergency.
2. Is currently licensed.
3. Does not have a provisional license.
4. Will be temporarily unable to provide services but is reasonably expected to resume services within 12 months.
(b) An inactive license may be issued for a period not to exceed 12 months but may be renewed by the agency for up to 12 additional months upon demonstration to the agency of progress toward reopening. A request by a licensee for an inactive license or to extend the previously approved inactive period must be submitted in writing to the agency, accompanied by written justification for the inactive license, which states the beginning and ending dates of inactivity and includes a plan for the transfer of any clients to other providers and appropriate licensure fees. Upon agency approval, the licensee shall notify clients of any necessary discharge or transfer as required by authorizing statutes or applicable rules. The beginning of the inactive licensure period shall be the date the provider ceases operations. The end of the inactive period shall become the license expiration date, and all licensure fees must be current, must be paid in full, and may be prorated. Reactivation of an inactive license requires the prior approval by the agency of a renewal application, including payment of licensure fees and agency inspections indicating compliance with all requirements of this part and applicable rules and statutes.
(4) The agency may adopt rules relating to emergency management planning, communications, and operations. Licensees providing residential or inpatient services must utilize an online database approved by the agency to report information to the agency regarding the provider’s emergency status, planning, or operations.
History.—s. 54, ch. 2009-223.
408.831 Denial, suspension, or revocation of a license, registration, certificate, or application.—
(1) In addition to any other remedies provided by law, the agency may deny each application or suspend or revoke each license, registration, or certificate of entities regulated or licensed by it:
(a) If the applicant, licensee, or a licensee subject to this part which shares a common controlling interest with the applicant has failed to pay all outstanding fines, liens, or overpayments assessed by final order of the agency or final order of the Centers for Medicare and Medicaid Services, not subject to further appeal, unless a repayment plan is approved by the agency; or
(b) For failure to comply with any repayment plan.
(2) In reviewing any application requesting a change of ownership or change of the licensee, registrant, or certificateholder, the transferor shall, prior to agency approval of the change, repay or make arrangements to repay any amounts owed to the agency. Should the transferor fail to repay or make arrangements to repay the amounts owed to the agency, the issuance of a license, registration, or certificate to the transferee shall be delayed until repayment or until arrangements for repayment are made.
(3) This section provides standards of enforcement applicable to all entities licensed or regulated by the Agency for Health Care Administration. This section controls over any conflicting provisions of chapters 39, 383, 390, 391, 394, 395, 400, 408, 429, 468, 483, and 765 or rules adopted pursuant to those chapters.
History.—s. 12, ch. 2002-400; s. 32, ch. 2003-57; s. 28, ch. 2006-71; s. 9, ch. 2006-192; s. 78, ch. 2006-197; s. 55, ch. 2009-223.
408.832 Conflicts.—In case of conflict between the provisions of this part and the authorizing statutes governing the licensure of health care providers by the Agency for Health Care Administration found in s. 112.0455 and chapters 383, 390, 394, 395, 400, 429, 440, 483, and 765, the provisions of this part shall prevail.
History.—s. 10, ch. 2006-192; s. 93, ch. 2007-5; s. 133, ch. 2007-230.
PART III
HEALTH INSURANCE ACCESS408.909 Health flex plans.
408.9091 Cover Florida Health Care Access Program.
408.910 Florida Health Choices Program.
408.909 Health flex plans.—
(1) INTENT.—The Legislature finds that a significant proportion of the residents of this state are unable to obtain affordable health insurance coverage. Therefore, it is the intent of the Legislature to expand the availability of health care options for low-income uninsured state residents by encouraging health insurers, health maintenance organizations, health-care-provider-sponsored organizations, local governments, health care districts, or other public or private community-based organizations to develop alternative approaches to traditional health insurance which emphasize coverage for basic and preventive health care services. To the maximum extent possible, these options should be coordinated with existing governmental or community-based health services programs in a manner that is consistent with the objectives and requirements of such programs.
(2) DEFINITIONS.—As used in this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Office” means the Office of Insurance Regulation of the Financial Services Commission.
(c) “Enrollee” means an individual who has been determined to be eligible for and is receiving health care coverage under a health flex plan approved under this section.
(d) “Health care coverage” or “health flex plan coverage” means health care services that are covered as benefits under an approved health flex plan or that are otherwise provided, either directly or through arrangements with other persons, via a health flex plan on a prepaid per capita basis or on a prepaid aggregate fixed-sum basis.
(e) “Health flex plan” means a health plan approved under subsection (3) which guarantees payment for specified health care coverage provided to the enrollee who purchases coverage directly from the plan or through a small business purchasing arrangement sponsored by a local government.
(f) “Health flex plan entity” means a health insurer, health maintenance organization, health-care-provider-sponsored organization, local government, health care district, other public or private community-based organization, or public-private partnership that develops and implements an approved health flex plan and is responsible for administering the health flex plan and paying all claims for health flex plan coverage by enrollees of the health flex plan.
(3) PROGRAM.—The agency and the office shall each approve or disapprove health flex plans that provide health care coverage for eligible participants. A health flex plan may limit or exclude benefits otherwise required by law for insurers offering coverage in this state, may cap the total amount of claims paid per year per enrollee, may limit the number of enrollees, or may take any combination of those actions. A health flex plan offering may include the option of a catastrophic plan supplementing the health flex plan.
(a) The agency shall develop guidelines for the review of applications for health flex plans and shall disapprove or withdraw approval of plans that do not meet or no longer meet minimum standards for quality of care and access to care. The agency shall ensure that the health flex plans follow standardized grievance procedures similar to those required of health maintenance organizations.
(b) The office shall develop guidelines for the review of health flex plan applications and provide regulatory oversight of health flex plan advertisement and marketing procedures. The office shall disapprove or shall withdraw approval of plans that:
1. Contain any ambiguous, inconsistent, or misleading provisions or any exceptions or conditions that deceptively affect or limit the benefits purported to be assumed in the general coverage provided by the health flex plan;
2. Provide benefits that are unreasonable in relation to the premium charged or contain provisions that are unfair or inequitable or contrary to the public policy of this state, that encourage misrepresentation, or that result in unfair discrimination in sales practices;
3. Cannot demonstrate that the health flex plan is financially sound and that the applicant is able to underwrite or finance the health care coverage provided; or
4. Cannot demonstrate that the applicant and its management are in compliance with the standards required under s. 624.404(3).
(c) The agency and the Financial Services Commission may adopt rules as needed to administer this section.
(4) LICENSE NOT REQUIRED.—Neither the licensing requirements of the Florida Insurance Code nor chapter 641, relating to health maintenance organizations, is applicable to a health flex plan approved under this section, unless expressly made applicable. However, for the purpose of prohibiting unfair trade practices, health flex plans are considered to be insurance subject to the applicable provisions of part IX of chapter 626, except as otherwise provided in this section.
(5) ELIGIBILITY.—Eligibility to enroll in an approved health flex plan is limited to residents of this state who:
(a)1. Have a family income equal to or less than 300 percent of the federal poverty level;
2. Are not covered by a private insurance policy and are not eligible for coverage through a public health insurance program, such as Medicare or Medicaid, or another public health care program, such as Kidcare, and have not been covered at any time during the past 6 months, except that:
a. A person who was covered under an individual health maintenance contract issued by a health maintenance organization licensed under part I of chapter 641 which was also an approved health flex plan on October 1, 2008, may apply for coverage in the same health maintenance organization’s health flex plan without a lapse in coverage if all other eligibility requirements are met; or
b. A person who was covered under Medicaid or Kidcare and lost eligibility for the Medicaid or Kidcare subsidy due to income restrictions within 90 days prior to applying for health care coverage through an approved health flex plan may apply for coverage in a health flex plan without a lapse in coverage if all other eligibility requirements are met; and
3. Have applied for health care coverage as an individual through an approved health flex plan and have agreed to make any payments required for participation, including periodic payments or payments due at the time health care services are provided; or
(b) Are part of an employer group of which at least 75 percent of the employees have a family income equal to or less than 300 percent of the federal poverty level and the employer group is not covered by a private health insurance policy and has not been covered at any time during the past 6 months. If the health flex plan entity is a health insurer, health plan, or health maintenance organization licensed under Florida law, only 50 percent of the employees must meet the income requirements for the purpose of this paragraph.
(6) RECORDS.—Each health flex plan shall maintain enrollment data and reasonable records of its losses, expenses, and claims experience and shall make those records reasonably available to enable the office to monitor and determine the financial viability of the health flex plan, as necessary. Provider networks and total enrollment by area shall be reported to the agency biannually to enable the agency to monitor access to care.
(7) NOTICE.—The denial of coverage by a health flex plan, or the nonrenewal or cancellation of coverage, must be accompanied by the specific reasons for denial, nonrenewal, or cancellation. Notice of nonrenewal or cancellation must be provided at least 45 days in advance of the nonrenewal or cancellation, except that 10 days’ written notice must be given for cancellation due to nonpayment of premiums. If the health flex plan fails to give the required notice, the health flex plan coverage must remain in effect until notice is appropriately given.
(8) NONENTITLEMENT.—Coverage under an approved health flex plan is not an entitlement, and a cause of action does not arise against the state, a local government entity, or any other political subdivision of this state, or against the agency, for failure to make coverage available to eligible persons under this section.
(9) PROGRAM EVALUATION.—The agency and the office shall evaluate the pilot program and its effect on the entities that seek approval as health flex plans, on the number of enrollees, and on the scope of the health care coverage offered under a health flex plan; shall provide an assessment of the health flex plans and their potential applicability in other settings; shall use health flex plans to gather more information to evaluate low-income consumer driven benefit packages; and shall, by January 1, 2005, and annually thereafter, jointly submit a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives.
(10) EXPIRATION.—This section expires July 1, 2013.
History.—s. 1, ch. 2002-389; s. 441, ch. 2003-261; s. 5, ch. 2003-405; s. 2, ch. 2004-270; s. 17, ch. 2004-297; s. 2, ch. 2005-231; s. 2, ch. 2008-32; s. 1, ch. 2008-118; s. 2, ch. 2011-195.
408.9091 Cover Florida Health Care Access Program.—
(1) SHORT TITLE.—This section may be cited as the “Cover Florida Health Care Access Program Act.”
(2) LEGISLATIVE INTENT.—The Legislature finds that a significant number of state residents are unable to obtain affordable health insurance coverage. The Legislature also finds that existing health flex plan coverage has had limited participation due in part to narrow eligibility restrictions as well as minimal benefit options for catastrophic and emergency care coverage. Therefore, it is the intent of the Legislature to expand the availability of health care options for uninsured residents by developing an affordable health care product that emphasizes coverage for basic and preventive health care services; provides inpatient hospital, urgent, and emergency care services; and is offered statewide by approved health insurers, health maintenance organizations, health-care-provider-sponsored organizations, or health care districts.
(3) DEFINITIONS.—As used in this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Cover Florida plan” means a consumer choice benefit plan approved under this section which guarantees payment or coverage for specified benefits provided to an enrollee.
(c) “Cover Florida plan coverage” means health care services that are covered as benefits under a Cover Florida plan.
(d) “Cover Florida plan entity” means a health insurer, health maintenance organization, health-care-provider-sponsored organization, or health care district that develops and implements a Cover Florida plan and is responsible for administering the plan and paying all claims for Cover Florida plan coverage by enrollees.
(e) “Cover Florida Plus” means a supplemental insurance product, such as for additional catastrophic coverage or dental, vision, or cancer coverage, approved under this section and offered to all enrollees.
(f) “Enrollee” means an individual who has been determined to be eligible for and is receiving health insurance coverage under a Cover Florida plan.
(g) “Office” means the Office of Insurance Regulation of the Financial Services Commission.
(4) PROGRAM.—The agency and the office shall jointly establish and administer the Cover Florida Health Care Access Program.
(a) General Cover Florida plan components must require that:
1. Plans are offered on a guaranteed-issue basis to enrollees, subject to exclusions for preexisting conditions approved by the office and the agency.
2. Plans are portable such that the enrollee remains covered regardless of employment status or the cost-sharing of premiums.
3. Plans provide for cost containment through limits on the number of services, caps on benefit payments, and copayments for services.
4. A Cover Florida plan entity makes all benefit plan and marketing materials available in English and Spanish.
5. In order to provide for consumer choice, Cover Florida plan entities develop two alternative benefit option plans having different cost and benefit levels, including at least one plan that provides catastrophic coverage.
6. Plans without catastrophic coverage provide coverage options for services including, but not limited to:
a. Preventive health services, including immunizations, annual health assessments, well-woman and well-care services, and preventive screenings such as mammograms, cervical cancer screenings, and noninvasive colorectal or prostate screenings.
b. Incentives for routine preventive care.
c. Office visits for the diagnosis and treatment of illness or injury.
d. Office surgery, including anesthesia.
e. Behavioral health services.
f. Durable medical equipment and prosthetics.
g. Diabetic supplies.
7. Plans providing catastrophic coverage, at a minimum, provide coverage options for all of the services listed under subparagraph 6.; however, such plans may include, but are not limited to, coverage options for:
a. Inpatient hospital stays.
b. Hospital emergency care services.
c. Urgent care services.
d. Outpatient facility services, outpatient surgery, and outpatient diagnostic services.
8. All plans offer prescription drug benefit coverage, use a prescription drug manager, or offer a discount drug card.
9. Plan enrollment materials provide information in plain language on policy benefit coverage, benefit limits, cost-sharing requirements, and exclusions and a clear representation of what is not covered in the plan. Such enrollment materials must include a standard disclosure form adopted by rule by the Financial Services Commission, to be reviewed and executed by all consumers purchasing Cover Florida plan coverage.
10. Plans offered through a qualified employer meet the requirements of s. 125 of the Internal Revenue Code.
(b) Guidelines shall be developed to ensure that Cover Florida plans meet minimum standards for quality of care and access to care. The agency shall ensure that the Cover Florida plans follow standardized grievance procedures.
(c) Changes in Cover Florida plan benefits, premiums, and policy forms are subject to regulatory oversight by the office and the agency as provided under rules adopted by the Financial Services Commission and the agency.
(d) The agency, the office, and the Executive Office of the Governor shall develop a public awareness program to be implemented throughout the state for the promotion of the Cover Florida Health Care Access Program.
(e) Public or private entities may design programs to encourage Floridians to participate in the Cover Florida Health Care Access Program or to encourage employers to cosponsor some share of Cover Florida plan premiums for employees.
(5) PLAN PROPOSALS.—The agency and the office shall announce, no later than July 1, 2008, an invitation to negotiate for Cover Florida plan entities to design a Cover Florida plan proposal in which benefits and premiums are specified.
(a) The invitation to negotiate shall include guidelines for the review of Cover Florida plan applications, policy forms, and all associated forms and provide regulatory oversight of Cover Florida plan advertisement and marketing procedures. A plan shall be disapproved or withdrawn if the plan:
1. Contains any ambiguous, inconsistent, or misleading provisions or any exceptions or conditions that deceptively affect or limit the benefits purported to be assumed in the general coverage provided by the plan;
2. Provides benefits that are unreasonable in relation to the premium charged or contains provisions that are unfair or inequitable, that are contrary to the public policy of this state, that encourage misrepresentation, or that result in unfair discrimination in sales practices;
3. Cannot demonstrate that the plan is financially sound and that the applicant is able to underwrite or finance the health care coverage provided;
4. Cannot demonstrate that the applicant and its management are in compliance with the standards required under s. 624.404(3); or
5. Does not guarantee that enrollees may participate in the Cover Florida plan entity’s comprehensive network of providers, as determined by the office, the agency, and the contract.
(b) The agency and the office may announce an invitation to negotiate for the design of Cover Florida Plus products to companies that offer supplemental insurance, discount medical plan organizations licensed under part II of chapter 636, or prepaid health clinics licensed under part II of chapter 641.
(c) The agency and office shall approve at least one Cover Florida plan entity having an existing statewide network of providers and may approve at least one regional network plan in each existing Medicaid area.
(6) LICENSE NOT REQUIRED.—
(a) The licensing requirements of the Florida Insurance Code and chapter 641 relating to health maintenance organizations do not apply to a Cover Florida plan approved under this section unless expressly made applicable. However, for the purpose of prohibiting unfair trade practices, Cover Florida plans are considered to be insurance subject to the applicable provisions of part IX of chapter 626 except as otherwise provided in this section.
(b) Cover Florida plans are not covered by the Florida Life and Health Insurance Guaranty Association under part III of chapter 631 or by the Health Maintenance Organization Consumer Assistance Plan under part IV of chapter 631.
(7) ELIGIBILITY.—Eligibility to enroll in a Cover Florida plan is limited to residents of this state who meet all of the following requirements:
(a) Are between 19 and 64 years of age, inclusive.
(b) Are not covered by a private insurance policy and are not eligible for coverage through a public health insurance program, such as Medicare, Medicaid, or Kidcare, unless eligibility for coverage lapses due to no longer meeting income or categorical requirements.
(c) Have not been covered by any health insurance program at any time during the past 6 months, unless coverage under a health insurance program was terminated within the previous 6 months due to:
1. Loss of a job that provided an employer-sponsored health benefit plan;
2. Exhaustion of coverage that was continued under COBRA or continuation-of-coverage requirements under s. 627.6692;
3. Reaching the limiting age under the policy; or
4. Death of, or divorce from, a spouse who was provided an employer-sponsored health benefit plan.
(d) Have applied for health care coverage through a Cover Florida plan and have agreed to make any payments required for participation, including periodic payments or payments due at the time health care services are provided.
(8) RECORDS.—Each Cover Florida plan must maintain enrollment data and provide network data and reasonable records to enable the office and the agency to monitor plans and to determine the financial viability of the Cover Florida plan, as necessary.
(9) NONENTITLEMENT.—Coverage under a Cover Florida plan is not an entitlement, and a cause of action does not arise against the state, a local government entity, any other political subdivision of the state, or the agency or the office for failure to make coverage available to eligible persons under this section.
(10) PROGRAM EVALUATION.—The agency and the office shall:
(a) Evaluate the Cover Florida Health Care Access Program and its effect on the entities that seek approval as Cover Florida plans, on the number of enrollees, and on the scope of the health care coverage offered under a Cover Florida plan.
(b) Provide an assessment of the Cover Florida plans and their potential applicability in other settings.
(c) Use Cover Florida plans to gather more information to evaluate low-income, consumer-driven benefit packages.
(d) Jointly submit by March 1, 2009, and annually thereafter, a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives which provides the information specified in paragraphs (a)-(c) and recommendations relating to the successful implementation and administration of the program.
(11) RULEMAKING AUTHORITY.—The agency and the Financial Services Commission may adopt rules pursuant to ss. 120.536(1) and 120.54 as needed to administer this section.
History.—s. 3, ch. 2008-32.
408.910 Florida Health Choices Program.—
(1) LEGISLATIVE INTENT.—The Legislature finds that a significant number of the residents of this state do not have adequate access to affordable, quality health care. The Legislature further finds that increasing access to affordable, quality health care can be best accomplished by establishing a competitive market for purchasing health insurance and health services. It is therefore the intent of the Legislature to create the Florida Health Choices Program to:
(a) Expand opportunities for Floridians to purchase affordable health insurance and health services.
(b) Preserve the benefits of employment-sponsored insurance while easing the administrative burden for employers who offer these benefits.
(c) Enable individual choice in both the manner and amount of health care purchased.
(d) Provide for the purchase of individual, portable health care coverage.
(e) Disseminate information to consumers on the price and quality of health services.
(f) Sponsor a competitive market that stimulates product innovation, quality improvement, and efficiency in the production and delivery of health services.
(2) DEFINITIONS.—As used in this section, the term:
(a) “Corporation” means the Florida Health Choices, Inc., established under this section.
(b) “Corporation’s marketplace” means the single, centralized market established by the program that facilitates the purchase of products made available in the marketplace.
(c) “Health insurance agent” means an agent licensed under part IV of chapter 626.
(d) “Insurer” means an entity licensed under chapter 624 which offers an individual health insurance policy or a group health insurance policy, a preferred provider organization as defined in s. 627.6471, an exclusive provider organization as defined in s. 627.6472, or a health maintenance organization licensed under part I of chapter 641, or a prepaid limited health service organization or discount medical plan organization licensed under chapter 636.
(e) “Program” means the Florida Health Choices Program established by this section.
(3) PROGRAM PURPOSE AND COMPONENTS.—The Florida Health Choices Program is created as a single, centralized market for the sale and purchase of various products that enable individuals to pay for health care. These products include, but are not limited to, health insurance plans, health maintenance organization plans, prepaid services, service contracts, and flexible spending accounts. The components of the program include:
(a) Enrollment of employers.
(b) Administrative services for participating employers, including:
1. Assistance in seeking federal approval of cafeteria plans.
2. Collection of premiums and other payments.
3. Management of individual benefit accounts.
4. Distribution of premiums to insurers and payments to other eligible vendors.
5. Assistance for participants in complying with reporting requirements.
(c) Services to individual participants, including:
1. Information about available products and participating vendors.
2. Assistance with assessing the benefits and limits of each product, including information necessary to distinguish between policies offering creditable coverage and other products available through the program.
3. Account information to assist individual participants with managing available resources.
4. Services that promote healthy behaviors.
(d) Recruitment of vendors, including insurers, health maintenance organizations, prepaid clinic service providers, provider service networks, and other providers.
(e) Certification of vendors to ensure capability, reliability, and validity of offerings.
(f) Collection of data, monitoring, assessment, and reporting of vendor performance.
(g) Information services for individuals and employers.
(h) Program evaluation.
(4) ELIGIBILITY AND PARTICIPATION.—Participation in the program is voluntary and shall be available to employers, individuals, vendors, and health insurance agents as specified in this subsection.
(a) Employers eligible to enroll in the program include:
1. Employers that meet criteria established by the corporation and elect to make their employees eligible through the program.
2. Fiscally constrained counties described in s. 218.67.
3. Municipalities having populations of fewer than 50,000 residents.
4. School districts in fiscally constrained counties.
5. Statutory rural hospitals.
(b) Individuals eligible to participate in the program include:
1. Individual employees of enrolled employers.
2. State employees not eligible for state employee health benefits.
3. State retirees.
4. Medicaid participants who opt out.
(c) Employers who choose to participate in the program may enroll by complying with the procedures established by the corporation. The procedures must include, but are not limited to:
1. Submission of required information.
2. Compliance with federal tax requirements for the establishment of a cafeteria plan, pursuant to s. 125 of the Internal Revenue Code, including designation of the employer’s plan as a premium payment plan, a salary reduction plan that has flexible spending arrangements, or a salary reduction plan that has a premium payment and flexible spending arrangements.
3. Determination of the employer’s contribution, if any, per employee, provided that such contribution is equal for each eligible employee.
4. Establishment of payroll deduction procedures, subject to the agreement of each individual employee who voluntarily participates in the program.
5. Designation of the corporation as the third-party administrator for the employer’s health benefit plan.
6. Identification of eligible employees.
7. Arrangement for periodic payments.
8. Employer notification to employees of the intent to transfer from an existing employee health plan to the program at least 90 days before the transition.
(d) All eligible vendors who choose to participate and the products and services that the vendors are permitted to sell are as follows:
1. Insurers licensed under chapter 624 may sell health insurance policies, limited benefit policies, other risk-bearing coverage, and other products or services.
2. Health maintenance organizations licensed under part I of chapter 641 may sell health maintenance contracts, limited benefit policies, other risk-bearing products, and other products or services.
3. Prepaid limited health service organizations may sell products and services as authorized under part I of chapter 636, and discount medical plan organizations may sell products and services as authorized under part II of chapter 636.
4. Prepaid health clinic service providers licensed under part II of chapter 641 may sell prepaid service contracts and other arrangements for a specified amount and type of health services or treatments.
5. Health care providers, including hospitals and other licensed health facilities, health care clinics, licensed health professionals, pharmacies, and other licensed health care providers, may sell service contracts and arrangements for a specified amount and type of health services or treatments.
6. Provider organizations, including service networks, group practices, professional associations, and other incorporated organizations of providers, may sell service contracts and arrangements for a specified amount and type of health services or treatments.
7. Corporate entities providing specific health services in accordance with applicable state law may sell service contracts and arrangements for a specified amount and type of health services or treatments.
A vendor described in subparagraphs 3.-7. may not sell products that provide risk-bearing coverage unless that vendor is authorized under a certificate of authority issued by the Office of Insurance Regulation and is authorized to provide coverage in the relevant geographic area. Otherwise eligible vendors may be excluded from participating in the program for deceptive or predatory practices, financial insolvency, or failure to comply with the terms of the participation agreement or other standards set by the corporation.
(e) Eligible individuals may voluntarily continue participation in the program regardless of subsequent changes in job status or Medicaid eligibility. Individuals who join the program may participate by complying with the procedures established by the corporation. These procedures must include, but are not limited to:
1. Submission of required information.
2. Authorization for payroll deduction.
3. Compliance with federal tax requirements.
4. Arrangements for payment in the event of job changes.
5. Selection of products and services.
(f) Vendors who choose to participate in the program may enroll by complying with the procedures established by the corporation. These procedures may include, but are not limited to:
1. Submission of required information, including a complete description of the coverage, services, provider network, payment restrictions, and other requirements of each product offered through the program.
2. Execution of an agreement to comply with requirements established by the corporation.
3. Execution of an agreement that prohibits refusal to sell any offered non-risk-bearing product to a participant who elects to buy it.
4. Establishment of product prices based on age, gender, and location of the individual participant, which may include medical underwriting.
5. Arrangements for receiving payment for enrolled participants.
6. Participation in ongoing reporting processes established by the corporation.
7. Compliance with grievance procedures established by the corporation.
(g) Health insurance agents licensed under part IV of chapter 626 are eligible to voluntarily participate as buyers’ representatives. A buyer’s representative acts on behalf of an individual purchasing health insurance and health services through the program by providing information about products and services available through the program and assisting the individual with both the decision and the procedure of selecting specific products. Serving as a buyer’s representative does not constitute a conflict of interest with continuing responsibilities as a health insurance agent if the relationship between each agent and any participating vendor is disclosed before advising an individual participant about the products and services available through the program. In order to participate, a health insurance agent shall comply with the procedures established by the corporation, including:
1. Completion of training requirements.
2. Execution of a participation agreement specifying the terms and conditions of participation.
3. Disclosure of any appointments to solicit insurance or procure applications for vendors participating in the program.
4. Arrangements to receive payment from the corporation for services as a buyer’s representative.
(5) PRODUCTS.—
(a) The products that may be made available for purchase through the program include, but are not limited to:
1. Health insurance policies.
2. Health maintenance contracts.
3. Limited benefit plans.
4. Prepaid clinic services.
5. Service contracts.
6. Arrangements for purchase of specific amounts and types of health services and treatments.
7. Flexible spending accounts.
(b) Health insurance policies, health maintenance contracts, limited benefit plans, prepaid service contracts, and other contracts for services must ensure the availability of covered services.
(c) Products may be offered for multiyear periods provided the price of the product is specified for the entire period or for each separately priced segment of the policy or contract.
(d) The corporation shall provide a disclosure form for consumers to acknowledge their understanding of the nature of, and any limitations to, the benefits provided by the products and services being purchased by the consumer.
(e) The corporation must determine that making the plan available through the program is in the interest of eligible individuals and eligible employers in the state.
(6) PRICING.—Prices for the products and services sold through the program must be transparent to participants and established by the vendors. The corporation shall annually assess a surcharge for each premium or price set by a participating vendor. The surcharge may not be more than 2.5 percent of the price and shall be used to generate funding for administrative services provided by the corporation and payments to buyers’ representatives.
(7) THE MARKETPLACE PROCESS.—The program shall provide a single, centralized market for purchase of health insurance, health maintenance contracts, and other health products and services. Purchases may be made by participating individuals over the Internet or through the services of a participating health insurance agent. Information about each product and service available through the program shall be made available through printed material and an interactive Internet website. A participant needing personal assistance to select products and services shall be referred to a participating agent in his or her area.
(a) Participation in the program may begin at any time during a year after the employer completes enrollment and meets the requirements specified by the corporation pursuant to paragraph (4)(c).
(b) Initial selection of products and services must be made by an individual participant within 60 days after the date the individual’s employer qualified for participation. An individual who fails to enroll in products and services by the end of this period is limited to participation in flexible spending account services until the next annual enrollment period.
(c) Initial enrollment periods for each product selected by an individual participant must last at least 12 months, unless the individual participant specifically agrees to a different enrollment period.
(d) If an individual has selected one or more products and enrolled in those products for at least 12 months or any other period specifically agreed to by the individual participant, changes in selected products and services may only be made during the annual enrollment period established by the corporation.
(e) The limits established in paragraphs (b)-(d) apply to any risk-bearing product that promises future payment or coverage for a variable amount of benefits or services. The limits do not apply to initiation of flexible spending plans if those plans are not associated with specific high-deductible insurance policies or the use of spending accounts for any products offering individual participants specific amounts and types of health services and treatments at a contracted price.
(8) CONSUMER INFORMATION.—The corporation shall:
(a) Establish a secure website to facilitate the purchase of products and services by participating individuals. The website must provide information about each product or service available through the program.
(b) Inform individuals about other public health care programs.
(9) RISK POOLING.—The program may use methods for pooling the risk of individual participants and preventing selection bias. These methods may include, but are not limited to, a postenrollment risk adjustment of the premium payments to the vendors. The corporation may establish a methodology for assessing the risk of enrolled individual participants based on data reported annually by the vendors about their enrollees. Distribution of payments to the vendors may be adjusted based on the assessed relative risk profile of the enrollees in each risk-bearing product for the most recent period for which data is available.
(10) EXEMPTIONS.—
(a) Products, other than the products set forth in subparagraphs (4)(d)1.-4., sold as part of the program are not subject to the licensing requirements of the Florida Insurance Code, as defined in s. 624.01 or the mandated offerings or coverages established in part VI of chapter 627 and chapter 641.
(b) The corporation may act as an administrator as defined in s. 626.88 but is not required to be certified pursuant to part VII of chapter 626. However, a third party administrator used by the corporation must be certified under part VII of chapter 626.
(11) CORPORATION.—There is created the Florida Health Choices, Inc., which shall be registered, incorporated, organized, and operated in compliance with part III of chapter 112 and chapters 119, 286, and 617. The purpose of the corporation is to administer the program created in this section and to conduct such other business as may further the administration of the program.
(a) The corporation shall be governed by a 15-member board of directors consisting of:
1. Three ex officio, nonvoting members to include:
a. The Secretary of Health Care Administration or a designee with expertise in health care services.
b. The Secretary of Management Services or a designee with expertise in state employee benefits.
c. The commissioner of the Office of Insurance Regulation or a designee with expertise in insurance regulation.
2. Four members appointed by and serving at the pleasure of the Governor.
3. Four members appointed by and serving at the pleasure of the President of the Senate.
4. Four members appointed by and serving at the pleasure of the Speaker of the House of Representatives.
5. Board members may not include insurers, health insurance agents or brokers, health care providers, health maintenance organizations, prepaid service providers, or any other entity, affiliate or subsidiary of eligible vendors.
(b) Members shall be appointed for terms of up to 3 years. Any member is eligible for reappointment. A vacancy on the board shall be filled for the unexpired portion of the term in the same manner as the original appointment.
(c) The board shall select a chief executive officer for the corporation who shall be responsible for the selection of such other staff as may be authorized by the corporation’s operating budget as adopted by the board.
(d) Board members are entitled to receive, from funds of the corporation, reimbursement for per diem and travel expenses as provided by s. 112.061. No other compensation is authorized.
(e) There is no liability on the part of, and no cause of action shall arise against, any member of the board or its employees or agents for any action taken by them in the performance of their powers and duties under this section.
(f) The board shall develop and adopt bylaws and other corporate procedures as necessary for the operation of the corporation and carrying out the purposes of this section. The bylaws shall:
1. Specify procedures for selection of officers and qualifications for reappointment, provided that no board member shall serve more than 9 consecutive years.
2. Require an annual membership meeting that provides an opportunity for input and interaction with individual participants in the program.
3. Specify policies and procedures regarding conflicts of interest, including the provisions of part III of chapter 112, which prohibit a member from participating in any decision that would inure to the benefit of the member or the organization that employs the member. The policies and procedures shall also require public disclosure of the interest that prevents the member from participating in a decision on a particular matter.
(g) The corporation may exercise all powers granted to it under chapter 617 necessary to carry out the purposes of this section, including, but not limited to, the power to receive and accept grants, loans, or advances of funds from any public or private agency and to receive and accept from any source contributions of money, property, labor, or any other thing of value to be held, used, and applied for the purposes of this section.
(h) The corporation may establish technical advisory panels consisting of interested parties, including consumers, health care providers, individuals with expertise in insurance regulation, and insurers.
(i) The corporation shall:
1. Determine eligibility of employers, vendors, individuals, and agents in accordance with subsection (4).
2. Establish procedures necessary for the operation of the program, including, but not limited to, procedures for application, enrollment, risk assessment, risk adjustment, plan administration, performance monitoring, and consumer education.
3. Arrange for collection of contributions from participating employers and individuals.
4. Arrange for payment of premiums and other appropriate disbursements based on the selections of products and services by the individual participants.
5. Establish criteria for disenrollment of participating individuals based on failure to pay the individual’s share of any contribution required to maintain enrollment in selected products.
6. Establish criteria for exclusion of vendors pursuant to paragraph (4)(d).
7. Develop and implement a plan for promoting public awareness of and participation in the program.
8. Secure staff and consultant services necessary to the operation of the program.
9. Establish policies and procedures regarding participation in the program for individuals, vendors, health insurance agents, and employers.
10. Provide for the operation of a toll-free hotline to respond to requests for assistance.
11. Provide for initial, open, and special enrollment periods.
12. Evaluate options for employer participation which may conform with common insurance practices.
(12) REPORT.—Beginning in the 2009-2010 fiscal year, submit by February 1 an annual report to the Governor, the President of the Senate, and the Speaker of the House of Representatives documenting the corporation’s activities in compliance with the duties delineated in this section.
(13) PROGRAM INTEGRITY.—To ensure program integrity and to safeguard the financial transactions made under the auspices of the program, the corporation is authorized to establish qualifying criteria and certification procedures for vendors, require performance bonds or other guarantees of ability to complete contractual obligations, monitor the performance of vendors, and enforce the agreements of the program through financial penalty or disqualification from the program.
(14) EXEMPTION FROM PUBLIC RECORDS REQUIREMENTS.—
(a) Definitions.—For purposes of this subsection, the term:
1. “Buyer’s representative” means a participating insurance agent as described in paragraph (4)(g).
2. “Enrollee” means an employer who is eligible to enroll in the program pursuant to paragraph (4)(a).
3. “Participant” means an individual who is eligible to participate in the program pursuant to paragraph (4)(b).
4. “Proprietary confidential business information” means information, regardless of form or characteristics, that is owned or controlled by a vendor requesting confidentiality under this section; that is intended to be and is treated by the vendor as private in that the disclosure of the information would cause harm to the business operations of the vendor; that has not been disclosed unless disclosed pursuant to a statutory provision, an order of a court or administrative body, or a private agreement providing that the information may be released to the public; and that is information concerning:
a. Business plans.
b. Internal auditing controls and reports of internal auditors.
c. Reports of external auditors for privately held companies.
d. Client and customer lists.
e. Potentially patentable material.
f. A trade secret as defined in s. 688.002.
5. “Vendor” means a participating insurer or other provider of services as described in paragraph (4)(d).
(b) Public record exemptions.—
1. Personal identifying information of an enrollee or participant who has applied for or participates in the Florida Health Choices Program is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
2. Client and customer lists of a buyer’s representative held by the corporation are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
3. Proprietary confidential business information held by the corporation is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(c) Retroactive application.—The public record exemptions provided for in paragraph (b) apply to information held by the corporation before, on, or after the effective date of this exemption.
(d) Authorized release.—
1. Upon request, information made confidential and exempt pursuant to this subsection shall be disclosed to:
a. Another governmental entity in the performance of its official duties and responsibilities.
b. Any person who has the written consent of the program applicant.
c. The Florida Kidcare program for the purpose of administering the program authorized in ss. 409.810-409.821.
2. Paragraph (b) does not prohibit a participant’s legal guardian from obtaining confirmation of coverage, dates of coverage, the name of the participant’s health plan, and the amount of premium being paid.
(e) Penalty.—A person who knowingly and willfully violates this subsection commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(f) Review and repeal.—This subsection is subject to the Open Government Sunset Review Act in accordance with s. 119.15, and shall stand repealed on October 2, 2016, unless reviewed and saved from repeal through reenactment by the Legislature.
History.—s. 4, ch. 2008-32; s. 4, ch. 2011-195; s. 1, ch. 2011-197.
PART IV
HEALTH AND HUMAN SERVICESELIGIBILITY ACCESS SYSTEM
408.911 Short title.
408.913 Comprehensive Health and Human Services Eligibility Access System.
408.914 Phased implementation plan.
408.915 Eligibility pilot project.
408.916 Steering committee.
408.918 Florida 211 Network; uniform certification requirements.
408.911 Short title.—Sections 408.911-408.918 may be cited as the “Florida Health and Human Services Access Act.”
History.—s. 1, ch. 2002-223.
408.913 Comprehensive Health and Human Services Eligibility Access System.—
(1) The Agency for Health Care Administration shall develop a comprehensive, automated system for access to health care services. This system shall, to the greatest extent possible, use the capacity of existing automated systems so as to maximize the benefit of investments already made in information technology and minimize additional costs.
(2) The benefit eligibility component of the system shall include simplified access through coordination with information and referral telephone systems. This does not preclude use of other methods of application, including mail-in applications, office visits, or online applications via the Internet. The eligibility component of the system shall include:
(a) Improved access to eligibility-status information.
(b) Development and sharing of information with eligible individuals and families regarding choices available to them for using health care services.
(3) The state agencies providing the medical, clinical, and related health care support services for special populations, including frail elders, adults with disabilities, and children with special needs shall develop systems for these populations which integrate and coordinate care and improved communication. These systems must include development of standard protocols for care planning and assessment, a focus on family involvement, and methods to communicate across systems, including automated methods, in order to improve integration and coordination of services.
History.—s. 2, ch. 2002-223.
408.914 Phased implementation plan.—The Agency for Health Care Administration, in consultation with the Health Care Access Steering Committee created in s. 408.916, shall phase in the implementation of the Comprehensive Health and Human Services Eligibility Access System.
(1) The first phase of implementation shall be a pilot project in one or more counties to demonstrate the feasibility of integrating eligibility determination for health care services with information and referral services. The department shall, when selecting an area to be designated as a model area, give consideration to an entity that is a community care for the elderly lead agency and has developed, through a joint effort, an integrated service delivery information network.
(2) Upon demonstration of the feasibility of the first phase of implementation, and subject to appropriation of any necessary resources, the steering committee shall develop a detailed implementation plan for the care management component of the system. The implementation plan must include the steering committee’s recommendation of one or more state agencies that should be designated to implement the care management component of the system.
(3) Options for further implementation of the system may include a phased implementation of the eligibility component in additional sites before implementing the remaining components of the system or may include implementation of the care management and service system components along with the eligibility components.
History.—s. 3, ch. 2002-223; s. 115, ch. 2010-102.
408.915 Eligibility pilot project.—The Agency for Health Care Administration, in consultation with the steering committee established in s. 408.916, shall develop and implement a pilot project to integrate the determination of eligibility for health care services with information and referral services.
(1) The pilot project shall operate in one or more contiguous counties, as selected by the agency in consultation with the steering committee.
(2) The pilot project shall focus on developing, to the maximum extent possible, a process for eligibility application which:
(a) Uses a single uniform electronic application process, but permits applying for health services through various entry points, including information and referral providers, state agency program personnel or contracted providers, the mail, or the Internet;
(b) Is linked to a shared database that will have the capability to sort or store information by families as well as individuals;
(c) Permits electronic input and storage of data and electronic verification and exchange of information;
(d) Is compliant with the federal Health Insurance Portability and Accountability Act, as well as all other applicable state and federal confidentiality, financial, and insurance requirements;
(e) Includes an initial screening component for referring applicants to other health and human services programs provided through state agencies and the Florida Healthy Kids Corporation, including programs addressing developmental delays, developmental disabilities, chronic physical illness, mental health needs, substance abuse treatment needs, elder and aging needs, and other health care needs; and
(f) Includes the level of customer service available to applicants and participants in the pilot project.
(3) The information and referral provider in the site selected as the pilot project shall, at a minimum:
(a) Execute a memorandum of understanding with the local community volunteer placement centers;
(b) Implement, or be in the process of implementing, a shared, web-based, information and eligibility database with community health providers and funders;
(c) Provide comprehensive information and referral services 24 hours per day, 7 days per week;
(d) Agree, in writing, to become accredited within 3 years by a nationally recognized information and referral accrediting agency;
(e) Execute a memorandum of understanding with 911 and other emergency response agencies in the pilot area;
(f) Implement policies and structured training to effectively respond to crisis calls or obtain accreditation by a nationally recognized mental health or crisis accrediting agency;
(g) Obtain teletypewriter and multi-language accessibility, either on-site or through a translation service; and
(h) Develop resources to support and publicize information and referral services and provide ongoing education to the public on the availability of such services.
(4) The pilot project shall include eligibility determinations for the following programs:
(a) Medicaid under Title XIX of the Social Security Act.
(b) Medikids as created in s. 409.8132.
(c) Florida Healthy Kids as described in s. 624.91 and within eligibility guidelines provided in s. 409.814.
(d) Eligibility for Florida Kidcare services outside of the scope of Title XIX or Title XXI of the Social Security Act as provided in s. 409.814.
(e) State and local publicly funded health and social services programs as determined appropriate by the steering committee.
(5) If the Secretary of Health Care Administration, in consultation with the steering committee established in s. 408.916, determines that it would facilitate operation of the pilot project to obtain federal waiver authority, the appropriate state agency shall request such waiver authority from the appropriate federal agency.
History.—s. 4, ch. 2002-223; s. 116, ch. 2010-102.
408.916 Steering committee.—In order to guide the implementation of the pilot project, there is created a Health Care Access Steering Committee.
(1) The steering committee shall be composed of the following members:
(a) The Secretary of Health Care Administration.
(b) The Secretary of Children and Family Services.
(c) The Secretary of Elderly Affairs.
(d) The State Surgeon General.
(e) A representative of the Florida Alliance of Information and Referral Services.
(f) A representative of the Florida Healthy Kids Corporation.
(2) The steering committee may designate additional ad hoc members or technical advisors as the committee finds is appropriate.
(3) The Secretary of Health Care Administration shall be the chairperson of the steering committee.
(4) The steering committee shall provide oversight to the ongoing implementation of the pilot project, provide consultation and guidance on matters of policy, and provide oversight to the evaluation of the pilot project.
(5) The steering committee shall complete its activities by June 30, 2004, and the authorization for the steering committee ends on that date.
History.—s. 5, ch. 2002-223; s. 56, ch. 2008-6.
408.918 Florida 211 Network; uniform certification requirements.—
(1) The Legislature authorizes the planning, development, and, subject to appropriations, the implementation of a statewide Florida 211 Network, which shall serve as the single point of coordination for information and referral for health and human services. The objectives for establishing the Florida 211 Network shall be to:
(a) Provide comprehensive and cost-effective access to health and human services information.
(b) Improve access to accurate information by simplifying and enhancing state and local health and human services information and referral systems and by fostering collaboration among information and referral systems.
(c) Electronically connect local information and referral systems to each other, to service providers, and to consumers of information and referral services.
(d) Establish and promote standards for data collection and for distributing information among state and local organizations.
(e) Promote the use of a common dialing access code and the visibility and public awareness of the availability of information and referral services.
(f) Provide a management and administrative structure to support the Florida 211 Network and establish technical assistance, training, and support programs for information and referral-service programs.
(g) Test methods for integrating information and referral services with local and state health and human services programs and for consolidating and streamlining eligibility and case management processes.
(h) Provide access to standardized, comprehensive data to assist in identifying gaps and needs in health and human services programs.
(i) Provide a unified systems plan with a developed platform, taxonomy, and standards for data management and access.
(2) In order to participate in the Florida 211 Network, a 211 provider must be fully accredited by the National Alliance of Information and Referral Services or have received approval to operate, pending accreditation, from its affiliate, the Florida Alliance of Information and Referral Services. If any provider of information and referral services or other entity leases a 211 number from a local exchange company and is not authorized as described in this section, the Public Service Commission shall request that the Federal Communications Commission direct the local exchange company to revoke the use of the 211 number.
(3) The Florida Alliance of Information and Referral Services is the 211 collaborative organization for the state which is responsible for studying, designing, implementing, supporting, and coordinating the Florida 211 Network and for receiving federal grants.
History.—s. 7, ch. 2002-223; s. 56, ch. 2009-223.